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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Medtronic Cardiac Rhythm Disease Management.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01370564
First received: June 8, 2011
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Heart Failure
Drug: Diuretics
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Characterize the technical feasibility of the network based IPC system [ Time Frame: Baseline through Completion/Exit ] [ Designated as safety issue: No ]
    The proportion of study days that the delivered PtIS is based on the subjects' daily pressure state will be summarized.


Secondary Outcome Measures:
  • Characterize the rate of IPC setup system changes [ Time Frame: Baseline through Completion/Exit ] [ Designated as safety issue: No ]
    The frequency and reason for changes in the IPC setup will be documented and summarized.

  • Quantify subject compliance to daily PtIS [ Time Frame: Baseline through Completion/Exit ] [ Designated as safety issue: No ]
    The frequency of patient use and compliance with the daily IPC system will be summarized.

  • Estimate changes in clinical markers of heart failure and kidney function [ Time Frame: Baseline through Completion/Exit ] [ Designated as safety issue: No ]
    Changes in laboratory measurements (BNP, BUN, eGFR, etc.) and ePAD will be summarized.

  • Summarize adverse events [ Time Frame: Baseline through Completion/Exit ] [ Designated as safety issue: No ]
    All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.


Enrollment: 21
Study Start Date: June 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370564

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Virginia
Sentara Cardiovascular
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Philip Adamson, MD Oklahoma Cardiovascular Research
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01370564     History of Changes
Other Study ID Numbers: IPC
Study First Received: June 8, 2011
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart failure
Cardiac filling pressure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014