Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

NCT00354159 | Completed Results DMC

• 1 other identifier: 103
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 52

Brief Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.

Conditions

Heart Failure

Keywords

Implantable cardioverter defibrillator; Intracardiac pressures

Outcome Measures

Primary Outcomes (3)

• Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.

  A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.

  Within 6 months post-implant

• Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant

  A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.

  6 months post implant

• Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group

  The rate of HF-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.

  12 months post-implant

Secondary Outcomes (18)

• Cumulative Days in the Hospital for Heart Failure

  12 months post-implant

• Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group

  12 months post-implant

• Freedom From All Cause Death or Heart Failure Hospitalization

  12 months post-implant

• Relative Risk of All-cause Events

  12 months post-implant

• Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.

  12 months post implant

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Physicians have access to device-based hemodynamic monitor information to guide patient management

Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)

Control Arm

PLACEBO COMPARATOR

Physicians do not have access to device-based hemodynamic monitor information to guide patient management

Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)

Interventions

Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD) DEVICE

Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.

Also known as: Chronicle® IHM, Chronicle® ICD

Control Arm; Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Subjects with heart failure that only sometimes interferes with daily activities (New York Heart Association \[NYHA\] Class II (1)) or subjects with heart failure which severely limits daily activities (NYHA Class III (2)) at baseline
• Subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta blocker) for at least three months prior to the baseline evaluation.
• Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta blockers as determined by the study investigator for at least 30 days prior to baseline evaluation. (Stable is defined as no more than a 100% increase or a 50% decrease in dose.) If a subject is intolerant of ACE, ARB or beta blockers documented evidence must be available.
• Subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation
• To be considered for Chronicle ICD: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
• Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.
• Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.

You may not qualify if:

• Subjects with severe heart failure who should always be resting (NYHA Class IV(3)) or Stage D(4) refractory heart failure.
• Subjects with severe renal dysfunction.
• Subjects with severe non-cardiac condition limiting 12-month survival.
• Subjects in concurrent studies that may confound the results.
• (3)Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
• (4)Stage D refractory heart failure: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (52)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Long Beach Memorial

Long Beach, California, 90806, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Doctors Medical Center Modesto

Modesto, California, 95350, United States

Location

Yale University, School of Medicine

New Haven, Connecticut, 06510, United States

Location

Christiana Care Hospital

Newark, Delaware, 19718, United States

Location

University of FL Shands

Gainesville, Florida, 32610, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Crawford Long/Emory University Hospitals

Atlanta, Georgia, 30308, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Genesis Hospital Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

St Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mercy Hospital Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Mid America Heart Institute/St. Lukes

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Bryan LGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Mt Sinai Medical Center

New York, New York, 10029, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Presbyterian Hospital Mid Carolinas Cardiology

Charlotte, North Carolina, 28204, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Lehigh Valley Heart Specialists

Allentown, Pennsylvania, 18103, United States

Location

Lancaster Heart & Stroke Foundation

Lancaster, Pennsylvania, 17603, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spartanburg Regional

Spartanburg, South Carolina, 29303, United States

Location

Baptist Hospital

Nashville, Tennessee, 37203, United States

Location

St Thomas

Nashville, Tennessee, 37205, United States

Location

Baylor Research Institute

Dallas, Texas, 75226, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Reiter MJ, Stromberg KD, Whitman TA, Adamson PB, Benditt DG, Gold MR. Influence of intracardiac pressure on spontaneous ventricular arrhythmias in patients with systolic heart failure: insights from the REDUCEhf trial. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):272-8. doi: 10.1161/CIRCEP.113.000223. Epub 2013 Mar 20.

  PMID: 23515265 DERIVED

• Adamson PB, Conti JB, Smith AL, Abraham WT, Aaron MF, Aranda JM Jr, Baker J, Bourge RC, Warner-Stevenson L, Sparks B. Reducing events in patients with chronic heart failure (REDUCEhf ) study design: continuous hemodynamic monitoring with an implantable defibrillator. Clin Cardiol. 2007 Nov;30(11):567-75. doi: 10.1002/clc.20250.

  PMID: 18000962 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The study was terminated early after 400 of an estimated 1300 subjects required were randomized. The study was terminated due to a pressure lead integrity issue based on analysis of pressure leads from other clinical trials.

Results Point of Contact

• Title: REDUCEhf Clinical Research Specialist
• Organization: Medtronic CRDM

medtronicCRMtrials@medtronic.com

1-800-328-2518

Study Officials

• Phillip Adamson, MD

  Oklahoma Heart Hospital

  STUDY CHAIR

• Michael Gold, MD

  Medical University of South Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 9, 2012
• Results First Posted: August 9, 2012

Record last verified: 2012-08

Locations

US (52)