Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00643279
• Collaborator: (none)
• Enrollment: 277
• Locations: 28
• Arms: 2
• Duration (Months): 121
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Chronicle Implantable Hemodynamic Monitor; Other: Standard of Care	N/A

Detailed Description

COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

After baseline evaluation and verification that entrance criteria were met, all subjects were implanted with a Chronicle IHM and pressure sensor lead. Following successful implantation, subjects were randomized to either the CHRONICLE group or CONTROL group. Subjects randomized to the CHRONICLE group were managed using Chronicle, specifically trended RV and estimated PA pressure, heart rate and activity data, whereas subjects randomized to the CONTROL group were treated conventionally without the use of the Chronicle data. In the case that implantation was not successful, subjects were exited from the study if no procedure related adverse events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.

Subjects remained randomized until their six month clinic visit had been completed. Following the subject's six month visit, clinicians were granted access to the CONTROL subject's trended Chronicle data on the Chronicle website, and subjects were seen in the clinic for a protocol-required visit every six months until exit from the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 277 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHRONICLE Subjects randomized to the CHRONICLE group were managed using data from an implantable hemodynamic monitoring (IHM) device, including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The Chronicle IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.	Device: Chronicle Implantable Hemodynamic Monitor; Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
Placebo Comparator: CONTROL Subjects randomized to the CONTROL group implanted with the Chronicle implantable hemodynamic monitoring (IHM) device, but the intracardiac diagnostic information was blinded to both the patient and the physician during the randomized period of the study. Subjects were managed conventionally with standard of care. Physicians and patients have access to the intracardiac data after the randomized period of the study is over, at 6 months.	Other: Standard of Care; Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.

Outcome Measures

Primary Outcome Measures

1. Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. [Within 6 months post-implant]

   A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.

2. Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months. [Within 6 months post-implant]

   A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters. Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.

3. Rate of Heart Failure-related Hospital Equivalents. [6 Months post-implant]

   Hospital equivalents (HE) were defined to include the following events: Heart failure-related hospital admissions for 24 hours or longer Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).

Secondary Outcome Measures

1. Health Care Utilization [6 Months post-implant]

   Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.

2. Days Hospitalization Free [6 Months post-implant]

   The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.

3. Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged" [6 Months post-implant]

   Worsened, Improved and Unchanged were defined as follows: Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened.

4. Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire [6 Months post-implant]

   Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life). Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis.

5. New York Heart Association (NYHA) Class [6 Months post-implant]

   New York Heart Association (NYHA) Classifications were defined as follows: Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

6. Distance Walked During a Six Minute Hall Walk [6 Months post-implant]

   Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV

• Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation

• Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation

Exclusion Criteria:

• Subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation

• Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted)

• Subjects who are on continuous positive inotropic therapy

• Subjects with known atrial or ventricular septal defects

• Subjects with mechanical right heart valves

• Subjects with stenotic tricuspid or pulmonary valves

• Subjects with a presently implanted non-compatible pacemaker or ICD

• Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months

• Subjects with a major cardiovascular event within 3 months prior to baseline evaluation

• Subjects with a severe non-cardiac condition limiting 6 month survival

• Subjects with a primary diagnosis of pulmonary artery hypertension

• Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis

• Subjects enrolled in concurrent studies that may confound the results of this study

• Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States
2	Loma Linda University Medical Center	Loma Linda	California	United States
3	UCLA Medical Center	Los Angeles	California	United States
4	University of Southern California	Los Angeles	California	United States
5	University of Florida - Shands	Gainesville	Florida	United States
6	Crawford LongHospital	Atlanta	Georgia	United States
7	Prairie Heart Institute	Springfield	Illinois	United States
8	Parkview Memorial Hospital	Fort Wayne	Indiana	United States
9	New England Medical Center	Boston	Massachusetts	United States
10	St. Paul Heart	Saint Paul	Minnesota	United States
11	Mid America Heart Institute	Kansas City	Missouri	United States
12	Robert Wood Johnson Medical Center	New Brunswick	New Jersey	United States
13	Newark Beth Israel	Newark	New Jersey	United States
14	New York Presbyterian - Columbia	New York	New York	United States
15	Duke University	Chapel Hill	North Carolina	United States
16	University of Cincinnati	Cincinnati	Ohio	United States
17	The Ohio State University	Columbus	Ohio	United States
18	Oklahoma Cardiovascular Associates	Oklahoma City	Oklahoma	United States
19	University of Oklahoma	Oklahoma City	Oklahoma	United States
20	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States
21	Temple University Hospital	Philadelphia	Pennsylvania	United States
22	University of Pittsburgh	Pittsburgh	Pennsylvania	United States
23	Medical University of South Carolina	Charleston	South Carolina	United States
24	Baptist Memorial Hospital	Germantown	Tennessee	United States
25	St. Thomas Hospital	Nashville	Tennessee	United States
26	St. Luke's Episcopal Hospital/Texas Heart	Houston	Texas	United States
27	LDS Hospital	Salt Lake City	Utah	United States
28	University of Washington Medical Center	Seattle	Washington	United States

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Robert Bourge, MD, The University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00643279
• Other Study ID Numbers: COMPASS-HF
• First Posted: Mar 26, 2008
• Last Update Posted: Sep 16, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: implantable hemodynamic monitor; Intracardiac pressures
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	Recruitment began on March 13, 2003 and ended on November 16, 2004. All subjects were exited from the study on April 8, 2013. Twenty-nine US clinical centers participated in the COMPASS-HF study.
Pre-assignment Detail	Subjects were required to have a successful implant of the Chronicle® device prior to randomization. 277 subjects had an attempted implant, with 274 successfully implanted and randomized. 3 subjects had unsuccessful implant attempts and were exited prior to randomization.

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Period Title: Overall Study
STARTED	134	140
COMPLETED	118	127
NOT COMPLETED	16	13

Baseline Characteristics

Arm/Group Title	Treatment	Control	Total
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management	Total of all reporting groups
Overall Participants	134	140	274
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (14)	58 (13)	58 (14)
Sex: Female, Male (Count of Participants)
Female	59 44%	50 35.7%	109 39.8%
Male	75 56%	90 64.3%	165 60.2%
Region of Enrollment (participants) [Number]
United States	134 100%	140 100%	274 100%
New York Heart Association Class III (NYHA III) (Count of Participants)
Count of Participants [Participants]	112 83.6%	122 87.1%	234 85.4%
New York Heart Association Class IV (NYHA IV) (Count of Participants)
Count of Participants [Participants]	22 16.4%	18 12.9%	40 14.6%

Outcome Measures

1. Primary Outcome

Title	Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
Description	A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.
Time Frame	Within 6 months post-implant

Outcome Measure Data

Analysis Population Description

The analysis population for safety includes all subjects with an attempted implant of the Chronicle implantable hemodynamic monitoring device, including both successful implanted participants (274) and unsuccessful implanted participants (3). In total 277 participants were assessed for the safety objective.

Arm/Group Title	All Subjects With Attempted Implant
Arm/Group Description	All subjects with an attempted implant of a Chronicle IHM.
Measure Participants	277
Count of Participants [Participants]	277 206.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Subjects With Attempted Implant
	Comments
	Type of Statistical Test	Superiority
	Comments	Survival estimate at 6-months
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	6-month survival rate
	Estimated Value	91.5
	Confidence Interval	(1-Sided) 95%; 88.7 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.
Description	A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters. Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.
Time Frame	Within 6 months post-implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects Successfully Implanted
Arm/Group Description	All subjects successfully implanted with a Chronicle IHM system
Measure Participants	274
Count of Participants [Participants]	274 204.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Subjects With Attempted Implant
	Comments
	Type of Statistical Test	Superiority
	Comments	Survival estimate at 6-months
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	6-month survival rate
	Estimated Value	100
	Confidence Interval	(1-Sided) 95%; 98.9 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Rate of Heart Failure-related Hospital Equivalents.
Description	Hospital equivalents (HE) were defined to include the following events: Heart failure-related hospital admissions for 24 hours or longer Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	134	140
Mean (95% Confidence Interval) [Events]	0.63	0.81

4. Secondary Outcome

Title	Health Care Utilization
Description	Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	134	140
Number [Total number of events]	218	255

5. Secondary Outcome

Title	Days Hospitalization Free
Description	The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	134	140
Mean (95% Confidence Interval) [Days]	170.8	172.7

6. Secondary Outcome

Title	Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"
Description	Worsened, Improved and Unchanged were defined as follows: Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	134	140
Improved	56 41.8%	48 34.3%
Worsend	50 37.3%	66 47.1%
Unchanged	28 20.9%	26 18.6%

7. Secondary Outcome

Title	Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
Description	Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life). Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects completing a quality of life survey at the baseline visit and month 6 visit

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	117	127
Mean (Full Range) [Index score]	-12.5	-8.5

8. Secondary Outcome

Title	New York Heart Association (NYHA) Class
Description	New York Heart Association (NYHA) Classifications were defined as follows: Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized subjects with NYHA assessment completed at baseline and at 6 months were included in the analysis

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	113	122
NYHA I	7 5.2%	11 7.9%
NYHA II	39 29.1%	31 22.1%
NYHA III	61 45.5%	70 50%
NYHA IV	6 4.5%	10 7.1%

9. Secondary Outcome

Title	Distance Walked During a Six Minute Hall Walk
Description	Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.
Time Frame	6 Months post-implant

Outcome Measure Data

Analysis Population Description

All randomized patients completing a hall walk at baseline and 6 months.

Arm/Group Title	Treatment	Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management	Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Measure Participants	112	115
Mean (Standard Deviation) [Meters]	6.2 (98.8)	-8.2 (114.2)

Adverse Events

Time Frame	6 months
Arm/Group Title	Treatment		Control
Arm/Group Description	Physicians have access to device-based hemodynamic monitor information to guide patient management		Physicians do not have access to device-based hemodynamic monitor information to guide patient management
All Cause Mortality
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/134 (9.7%)		11/140 (7.9%)
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/134 (59%)		91/140 (65%)
Blood and lymphatic system disorders
Lab value abnormalities	3/134 (2.2%)	3	0/140 (0%)	0
Anemia	1/134 (0.7%)	1	0/140 (0%)	0
Cardiac disorders
Decompensation of heart failure	35/134 (26.1%)	57	43/140 (30.7%)	68
Volume overload	6/134 (4.5%)	10	16/140 (11.4%)	26
Volume depletion/dehydration	6/134 (4.5%)	6	5/140 (3.6%)	6
Angina pectoris	8/134 (6%)	8	1/140 (0.7%)	1
Cardiovascular procedure	4/134 (3%)	4	5/140 (3.6%)	6
Hypotension	1/134 (0.7%)	1	4/140 (2.9%)	4
Non-specific chest	3/134 (2.2%)	4	4/140 (2.9%)	4
Non sustained VT	1/134 (0.7%)	1	3/140 (2.1%)	3
Sustained VT	1/134 (0.7%)	1	3/140 (2.1%)	3
Acute MI/Cardiac Arrest	3/134 (2.2%)	3	3/140 (2.1%)	3
Atrial tachycardia	0/134 (0%)	0	1/140 (0.7%)	1
Paroxysmal atrial flutter/fibrillation	3/134 (2.2%)	4	1/140 (0.7%)	1
Persistent atrial flutter/fibrillation	1/134 (0.7%)	1	1/140 (0.7%)	1
Ventricular fibrillation/flutter	2/134 (1.5%)	2	2/140 (1.4%)	2
Hypertension	1/134 (0.7%)	1	2/140 (1.4%)	2
Electro Mechanical Dis-association	0/134 (0%)	0	1/140 (0.7%)	1
Sudden Cardiac Death	1/134 (0.7%)	1	1/140 (0.7%)	1
Edema/weight gain	1/134 (0.7%)	1	0/140 (0%)	0
Cardiac Transplant	1/134 (0.7%)	1	0/140 (0%)	0
Coronary Artery	1/134 (0.7%)	1	0/140 (0%)	0
Endocrine disorders
Hyponatremia	0/134 (0%)	0	1/140 (0.7%)	1
Hypokalemia	0/134 (0%)	0	2/140 (1.4%)	2
Gastrointestinal disorders
Ascites	0/134 (0%)	0	1/140 (0.7%)	1
General disorders
Urinary Tract Infection	1/134 (0.7%)	1	0/140 (0%)	0
Allergic Reaction	1/134 (0.7%)	1	0/140 (0%)	0
Infections and infestations
MRSA Infection	1/134 (0.7%)	1	0/140 (0%)	0
Sepsis	1/134 (0.7%)	1	0/140 (0%)	0
Injury, poisoning and procedural complications
Inhalant Poisoning from Cleaning Agents	0/134 (0%)	0	1/140 (0.7%)	1
Nervous system disorders
Stroke	1/134 (0.7%)	1	1/140 (0.7%)	1
Psychiatric disorders
Change in mental status	1/134 (0.7%)	2	0/140 (0%)	0
Renal and urinary disorders
Renal insufficiencies/failure	2/134 (1.5%)	2	1/140 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/134 (0.7%)	1	1/140 (0.7%)	1
Dyspnea/SOB	2/134 (1.5%)	2	0/140 (0%)	0
Worsening COPD	1/134 (0.7%)	1	0/140 (0%)	0
Pulmonary edema	1/134 (0.7%)	1	0/140 (0%)	0
Pleural effusion	1/134 (0.7%)	1	0/140 (0%)	0
Respiratory Failure/Arrest	1/134 (0.7%)	1	0/140 (0%)	0
Surgical and medical procedures
Elective Surgery	0/134 (0%)	0	1/140 (0.7%)	1
Vascular disorders
Peripheral Vascular Disease	1/134 (0.7%)	1	0/140 (0%)	0
Other (Not Including Serious) Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/134 (11.2%)		17/140 (12.1%)
Cardiac disorders
Sustained VT	0/134 (0%)	0	2/140 (1.4%)	2
Hypotension	2/134 (1.5%)	2	0/140 (0%)	0
Decompensated Heart Failure	5/134 (3.7%)	6	5/140 (3.6%)	5
Angina	2/134 (1.5%)	3	1/140 (0.7%)	1
Volume depletion/dehydration	2/134 (1.5%)	2	3/140 (2.1%)	3
Volume overload	4/134 (3%)	4	6/140 (4.3%)	10

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.