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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diuretics
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Cardiac filling pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ohio State University
  • Oklahoma Cardiovascular Research
  • Sentara Cardiovascular

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Daily diuretic adjustment

Arm Description

Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.

Outcomes

Primary Outcome Measures

Characterize the Technical Feasibility of the Network Based IPC System
The proportion of study days a PtIS is based on the subjects' daily pressure state

Secondary Outcome Measures

Characterize the Rate of IPC Setup System Changes
The frequency of changes in the IPC setup during the study (an average of 3-months).
Quantify Subject Compliance to Daily PtIS
The proporition of IPC days study subjects indicated they complied with their PtIS.
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).
Summarize Adverse Events
All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).

Full Information

First Posted
June 8, 2011
Last Updated
June 12, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01370564
Brief Title
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Acronym
IPC
Official Title
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Cardiac filling pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily diuretic adjustment
Arm Type
Other
Arm Description
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Intervention Type
Drug
Intervention Name(s)
Diuretics
Intervention Description
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Adamson, MD
Organizational Affiliation
Oklahoma Cardiovascular Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Sentara Cardiovascular
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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

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