IDENTIFY-HF: Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01486316
• Collaborator: (none)
• Enrollment: 24
• Locations: 11
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Heart Failure	Device: Reveal XT® Insertable Cardiac Monitor; Other: Heart Failure Risk Status Diagnostic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Control arm Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.	Device: Reveal XT® Insertable Cardiac Monitor; If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).; Other Names: Reveal XT® ; Other: Heart Failure Risk Status Diagnostic; The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
Experimental: Risk Status Guided Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).	Device: Reveal XT® Insertable Cardiac Monitor; If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).; Other Names: Reveal XT® ; Other: Heart Failure Risk Status Diagnostic; The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".

Outcome Measures

Primary Outcome Measures

1. Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events [0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)]

   Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score.

Other Outcome Measures

1. Correlation of HFRS Status With Actions/Testing [6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)]

   At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms. Because of the small number of subjects randomized, no formal statistical analyses were performed.

2. Clinical Status Measures [0 to 18 months post-implant]

   Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst)) Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient (or patient's legally authorized representative) is willing and able to provide written informed consent

• Patient is willing and able to comply with the protocol, including follow-up visits

• Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)

• Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor

• Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home

• Willing and able to transmit data via CareLink

Exclusion Criteria:

• Patient is pregnant

• Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures

• Endstage (Stage D or New York Heart Association class IV) heart failure

• Asymptomatic (Stage B or New York Heart Association class I) heart failure

• Severe aortic stenosis or insufficiency

• Existing insertable cardiac monitor implanted for more than 1 year

• Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device

• Severe renal impairment (estimated glomerular filtration rate <25mL/min)

• Myocardial infarction within prior 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Green	La Jolla	California	United States	92037
2	Aurora Denver Cardiology Associates	Aurora	Colorado	United States	80012
3	Spectrum Health	Grand Rapids	Michigan	United States	49503
4	The Valley Hospital	Ridgewood	New Jersey	United States	07450
5	Carolinas Medical Center/Sanger Heart & Vascular	Charlotte	North Carolina	United States	28203
6	The Ohio State University	Columbus	Ohio	United States	43210
7	Lancaster Heart & Stroke Foundation	Lancaster	Pennsylvania	United States	17602
8	Medical University of South Carolina	Charleston	South Carolina	United States	29425
9	St. Thomas Research Institute	Nashville	Tennessee	United States	37205
10	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
11	Heart Clinic PLLC	McAllen	Texas	United States	78503

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Chair: IDENTIFY-HF Team, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01486316
• Other Study ID Numbers: IDENTIFY-HF
• First Posted: Dec 6, 2011
• Last Update Posted: Jul 12, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	Control Arm	Risk Status Guided	No Implant	Implanted Not Randomized
Arm/Group Description	The Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Subjects who did not undergo an implant attempt and were not randomized.	Subject were implanted and not randomized
Period Title: Overall Study
STARTED	7	10	5	2
COMPLETED	3	7	0	0
NOT COMPLETED	4	3	5	2

Baseline Characteristics

Arm/Group Title	Control Arm	Risk Status Guided	Not Randomized	Total
Arm/Group Description	Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Subjects who were not randomized	Total of all reporting groups
Overall Participants	7	10	7	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.9 (7.6)	66.2 (15.3)	70.3 (9.7)	69.9 (12.0)
Sex: Female, Male (Count of Participants)
Female	4 57.1%	4 40%	4 57.1%	12 50%
Male	3 42.9%	6 60%	3 42.9%	12 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 14.3%	0 0%	0 0%	1 4.2%
White	6 85.7%	10 100%	7 100%	23 95.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
New York Heart Assocation (NYHA) Functional Classification (number) [Number]
NYHA Class II	5	6	3	14
NYHA Class III	2	4	4	10
LVEF (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	60.0 (4.1)	60.2 (10.7)	50.6 (11.6)	57.3 (10.2)
Heart Failure Stage (Number) [Number]
Stage C	6 85.7%	9 90%	5 71.4%	20 83.3%
Not available	1 14.3%	1 10%	2 28.6%	4 16.7%

Outcome Measures

1. Primary Outcome

Title	Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
Description	Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score.
Time Frame	0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Risk Status Guided
Arm/Group Description	The Control arm will be observed between months 13-18. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
Measure Participants	7	10
High/Very High Score & HF Event(s)	5 71.4%	2 20%
High/Very High Score, No HF Event(s)	2 28.6%	7 70%
HF Event(s), No High/Very High Score	0 0%	0 0%
No High/Very High Score or HF Event(s)	0 0%	1 10%

2. Other Pre-specified Outcome

Title	Correlation of HFRS Status With Actions/Testing
Description	At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms. Because of the small number of subjects randomized, no formal statistical analyses were performed.
Time Frame	6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)

Outcome Measure Data

Analysis Population Description

Only randomized subjects who did not exit prior to the period in which clinicians could utilized the HFRS score (6-18 months for HFRS Guided Arm, 13-18 months for Control Arm) were included in the analysis.

Arm/Group Title	Control Arm	Risk Status Guided
Arm/Group Description	The Control arm will be observed between months 13-18, and so only the subjects followed beyond 12 months are included in the analysis. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
Measure Participants	4	10
Measure Visits with High/Very High HFRS Score	3	58
Significant Weight Gain Reported	0	9
High Blood Pressure	0	5
HF Symptoms Reported	1	46
Medications Adjusted due to HFRS Score	1	18
Rate Control Meds Adjusted due to HFRS Score	0	1
Blood Pressure Meds Adjusted due to HFRS Score	0	4
Diuretics Adjusted due to HFRS Score	1	15
Directed to Clinic	0	9
Directed to Emergency Department	0	0
Directed to Hospital	0	0

3. Other Pre-specified Outcome

Title	Clinical Status Measures
Description	Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst)) Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate.
Time Frame	0 to 18 months post-implant

Outcome Measure Data

Analysis Population Description

Subjects randomized to the Risk Status Guided Arm

Arm/Group Title	Risk Status Guided	Control Arm
Arm/Group Description	Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".	The Control arm will be observed between months 13-18, and so only Control arm subjects followed beyond 12 months are included. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
Measure Participants	10	4
Measure Outcome of Patients During Guided Period	25	2
HF Event During Guided Period	6	1
High/Very High HFRS Score During Guided Period	7	1
Quality of Life Improvement During Guided Period	5	0
6 Minute Hall Walk Improved During Guided Period	3	0
Improved NYHA During Guided Period	4	0

Adverse Events

Time Frame	Adverse events were collected from the point of enrollment to the completion of follow-up (18 months).
Adverse Event Reporting Description	All subjects were assessed for adverse events through their follow-up visits as well as unscheduled visits as the adverse events occurred.
Arm/Group Title	Control Arm		Risk Status Guided
Arm/Group Description	Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status.The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".		Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
All Cause Mortality
	Control Arm		Risk Status Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/10 (0%)
Serious Adverse Events
	Control Arm		Risk Status Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		5/10 (50%)
Cardiac disorders
Acute Myocardial Infarction	1/7 (14.3%)	1	1/10 (10%)	1
Unstable Angina	1/7 (14.3%)	1	0/10 (0%)	0
Atrial Fribrillation	2/7 (28.6%)	2	2/10 (20%)	3
Cardiac Failure	1/7 (14.3%)	1	4/10 (40%)	4
Chest Pain	1/7 (14.3%)	1	0/10 (0%)	0
International normalizes ratio decreased	1/7 (14.3%)	1	0/10 (0%)	0
Sick Sinus Syndrome	1/7 (14.3%)	1	0/10 (0%)	0
Cardiac Arrest	0/7 (0%)	0	1/10 (10%)	1
Cardogenic Shock	0/7 (0%)	0	1/10 (10%)	1
Cardiomyopathy	0/7 (0%)	0	1/10 (10%)	1
Cardiac failure acute	0/7 (0%)	0	1/10 (10%)	3
Endocrine disorders
Renal Failure Acute	0/7 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/7 (14.3%)	1	1/10 (10%)	1
Pulmonary Vascular Disorder	1/7 (14.3%)	1	0/10 (0%)	0
Acute Respiratory Failure	0/7 (0%)	0	1/10 (10%)	1
Vascular disorders
Deep Vein Thrombosis	1/7 (14.3%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Control Arm		Risk Status Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		7/10 (70%)
Blood and lymphatic system disorders
Hyperkalaemia	1/7 (14.3%)	1	0/10 (0%)	0
Cardiac disorders
Atrial Fribillation	4/7 (57.1%)	6	4/10 (40%)	4
Cardiac Failure	3/7 (42.9%)	7	3/10 (30%)	3
Palpitations	1/7 (14.3%)	1	0/10 (0%)	0
Bradycardia	0/7 (0%)	0	1/10 (10%)	1
Chest Discomfort	0/7 (0%)	0	1/10 (10%)	1
Syncope	0/7 (0%)	0	1/10 (10%)	1
Cardiac Failure Congestive	0/7 (0%)	0	2/10 (20%)	2
General disorders
Cough	0/7 (0%)	0	1/10 (10%)	1
Metabolism and nutrition disorders
Drug Intolerance	1/7 (14.3%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.