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

NCT01370564 | Completed Phase 2 Results

• 1 other identifier: IPC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Keywords

Heart failure; Cardiac filling pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Characterize the Rate of IPC Setup System Changes

  Baseline through Completion/Exit (an average of 3-months)

• Quantify Subject Compliance to Daily PtIS

  Baseline through Completion/Exit (on average 3-months)

• Estimate Changes in Clinical Markers of Heart Failure and Kidney Function

  Baseline through Completion/Exit (an average of 3-months)

• Summarize Adverse Events

  Baseline through Completion/Exit (an average of 3-months)

• Estimate Changes in Clinical Markers of Heart Failure and Kidney Function

  Baseline through Completion/Exit (an average of 3-months)

Study Arms (1)

Daily diuretic adjustment

OTHER

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

Drug: Diuretics

Interventions

Diuretics DRUG

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

Daily diuretic adjustment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (3)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Sentara Cardiovascular

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

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

Results Point of Contact

• Title: Todd Fonseca, VP Clinical
• Organization: Medtronic

todd.fonseca@medtronic.com

763-526-8151

Study Officials

• Philip Adamson, MD

  Oklahoma Cardiovascular Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 11, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-06

Locations

US (3)