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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Diuretics

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Cardiovascular Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline through Completion/Exit (an average of 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the Rate of IPC Setup System Changes	The frequency of changes in the IPC setup during the study (an average of 3-months).	Baseline through Completion/Exit (an average of 3-months)
Quantify Subject Compliance to Daily PtIS	The proporition of IPC days study subjects indicated they complied with their PtIS.	Baseline through Completion/Exit (on average 3-months)
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).	Baseline through Completion/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.	Baseline through Completion/Exit (an average of 3-months)
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).	Baseline through Completion/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).	Baseline through Completion/Exit (an average of 3-months)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Philip Adamson, MD, Oklahoma Cardiovascular Research

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (ESTIMATE): June 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Heart failure; Cardiac filling pressure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: IPC (Other Identifier: University of Maia)