Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01370564
• Collaborator: (none)
• Enrollment: 21
• Locations: 3
• Arm: 1
• Duration (Months): 7
• Patients Per Site: 7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This chronic, prospective, non-randomized feasibility study is designed to evaluate the Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling pressures from the Chronicle device to provide timely medication adjustments (diuretics) to subjects.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Diuretics	Phase 2

Detailed Description

Subjects will be asked to transmit to the CareLink Network daily. Data specific to this study (subject's daily estimated Pulmonary Arterial Diastolic (ePAD) pressure values) will be extracted from the CareLink database and transferred to the IPC clinician website.

As each subject is enrolled, clinicians at each participating site will determine the appropriate target pressure range for each subject based on a review of the subject's pressure data. Each day after enrollment, the subject's current pressure data will be compared to a target pressure range that the clinician sets for that subject.

The patient instruction set (PtIS) is limited to a daily diuretic prescription and associated supplements, per physician discretion. The PtIS should not include adjustments of non-heart failure medications and should not include heart failure medications that are not indicated for day-to-day adjustments (e.g. ACE-Inhibitors, Angiotensin Receptor Blockers (ARBs), and Beta-Blockers). The PtIS will be sent from the IPC clinician website to the subject through a Patient Home Monitor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Daily diuretic adjustment Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.	Drug: Diuretics; Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.

Outcome Measures

Primary Outcome Measures

1. Characterize the Technical Feasibility of the Network Based IPC System [Baseline through Completion/Exit (an average of 3 months)]

   The proportion of study days a PtIS is based on the subjects' daily pressure state

Secondary Outcome Measures

1. Characterize the Rate of IPC Setup System Changes [Baseline through Completion/Exit (an average of 3-months)]

   The frequency of changes in the IPC setup during the study (an average of 3-months).

2. Quantify Subject Compliance to Daily PtIS [Baseline through Completion/Exit (on average 3-months)]

   The proporition of IPC days study subjects indicated they complied with their PtIS.

3. Estimate Changes in Clinical Markers of Heart Failure and Kidney Function [Baseline through Completion/Exit (an average of 3-months)]

   Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).

4. Summarize Adverse Events [Baseline through Completion/Exit (an average of 3-months)]

   All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.

5. Estimate Changes in Clinical Markers of Heart Failure and Kidney Function [Baseline through Completion/Exit (an average of 3-months)]

   Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).

6. Estimate Changes in Clinical Markers of Heart Failure and Kidney Function [Baseline through Completion/Exit (an average of 3-months)]

   Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle ICD device (Model 7286)

• Patients who have been prescribed daily diuretic therapy for the management of heart failure

• Patients currently participating in the COMPASS-HF Extension Phase Study (IDE #G020304)

• Patients willing and able to give informed consent

Exclusion Criteria:

• Patients with non-physiologic Right Ventricular (RV) pressure values

• Patients who have diuretic resistance

• Patients who have an estimated Glomerular Filtration Rate(eGFR) <30 ml/min (recorded within the last six months)

• Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303)

• Patients who do not have the ability to actively participate in the management of their own heart failure care (determine by physician discretion)(e.g. patient does not have ability to operate study equipment, patient does not have a history of compliance to sending CareLink transmissions)

• Patients who have a reasonable probability of needing a device replacement during the study (approximately two months)

• Patients enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial

• Patient who are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43210
2	Oklahoma Cardiovascular Research	Oklahoma City	Oklahoma	United States	73120
3	Sentara Cardiovascular	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Philip Adamson, MD, Oklahoma Cardiovascular Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01370564
• Other Study ID Numbers: IPC
• First Posted: Jun 10, 2011
• Last Update Posted: Jul 11, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Heart failure; Cardiac filling pressure
• Additional relevant MeSH terms: Heart Failure; Diuretics

Study Results

Participant Flow

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Period Title: Overall Study
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (12.7)
Sex: Female, Male (Count of Participants)
Female	6 28.6%
Male	15 71.4%
Region of Enrollment (participants) [Number]
United States	21 100%
New York Heart Association Classification (Count of Participants)
Class I	4 19%
Class II	12 57.1%
Class III	5 23.8%
Class IV	0 0%

Outcome Measures

1. Primary Outcome

Title	Characterize the Technical Feasibility of the Network Based IPC System
Description	The proportion of study days a PtIS is based on the subjects' daily pressure state
Time Frame	Baseline through Completion/Exit (an average of 3 months)

Outcome Measure Data

Analysis Population Description

The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor.

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Measure Days	1586
Mean (95% Confidence Interval) [percentage of days]	72

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Diuretic Adjustment
	Comments
	Type of Statistical Test	Other
	Comments	There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Rao-Scott estimator for clustered data
	Estimated Value	72
	Confidence Interval	(2-Sided) 95%; 65 to 78
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Characterize the Rate of IPC Setup System Changes
Description	The frequency of changes in the IPC setup during the study (an average of 3-months).
Time Frame	Baseline through Completion/Exit (an average of 3-months)

Outcome Measure Data

Analysis Population Description

The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Number (95% Confidence Interval) [changes per day]	0.2

3. Secondary Outcome

Title	Quantify Subject Compliance to Daily PtIS
Description	The proporition of IPC days study subjects indicated they complied with their PtIS.
Time Frame	Baseline through Completion/Exit (on average 3-months)

Outcome Measure Data

Analysis Population Description

The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Number (95% Confidence Interval) [proportion of compliant days]	0.994

4. Secondary Outcome

Title	Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Description	Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).
Time Frame	Baseline through Completion/Exit (an average of 3-months)

Outcome Measure Data

Analysis Population Description

Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Mean (Standard Deviation) [pg/dL]	-44.4 (388.8)

5. Secondary Outcome

Title	Summarize Adverse Events
Description	All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.
Time Frame	Baseline through Completion/Exit (an average of 3-months)

Outcome Measure Data

Analysis Population Description

All 21 subjects participating in the IPC study

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Yes	2 9.5%
No	19 90.5%
Yes	0 0%
No	21 100%
Yes	0 0%
No	21 100%
Yes	2 9.5%
No	19 90.5%
Yes	3 14.3%
No	18 85.7%

6. Secondary Outcome

Title	Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Description	Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).
Time Frame	Baseline through Completion/Exit (an average of 3-months)

Outcome Measure Data

Analysis Population Description

Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit.

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Mean (Standard Deviation) [mL/min per 1.73 m^2]	0 (14.2)

7. Secondary Outcome

Title	Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Description	Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).
Time Frame	Baseline through Completion/Exit (an average of 3-months)

Outcome Measure Data

Analysis Population Description

Subjects with blood urea nitrogen values at both the baseline and study exit visits

Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Measure Participants	21
Mean (Standard Deviation) [mg/dL]	1 (6.2)

Adverse Events

Time Frame	All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
Arm/Group Title	Daily Diuretic Adjustment
Arm/Group Description	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
All Cause Mortality
	Daily Diuretic Adjustment
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Serious Adverse Events
	Daily Diuretic Adjustment
	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)
Cardiac disorders
Cardiac Failure	1/21 (4.8%)	1
Myocardial Infarction	1/21 (4.8%)	1
Psychiatric disorders
Mental status change	1/21 (4.8%)	1
Other (Not Including Serious) Adverse Events
	Daily Diuretic Adjustment
	Affected / at Risk (%)	# Events
Total	4/21 (19%)
Cardiac disorders
Cardiac failure	1/21 (4.8%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/21 (4.8%)	1
Infections and infestations
Urinary tract infection	1/21 (4.8%)	1
Metabolism and nutrition disorders
Hyperglycaemia	2/21 (9.5%)	2
Hyponatraemia	1/21 (4.8%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/21 (4.8%)	1

Limitations/Caveats

The IPC study was a research feasibility study and was not powered to test any specific stastistical hypotheses.

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.