Clinical trial NCT00354159: Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
Official title: Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic HF (REDUCEhf)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Implantable cardioverter defibrillator
Intracardiac pressures
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

  1. 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.
  2. 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.
timeFrame: Within 6 months post-implant
measure: Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant
timeFrame: 6 months post implant
measure: Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group
timeFrame: 12 months post-implant
Secondary outcomes:
measure: Cumulative Days in the Hospital for Heart Failure
timeFrame: 12 months post-implant
measure: Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group
timeFrame: 12 months post-implant
measure: Freedom From All Cause Death or Heart Failure Hospitalization
timeFrame: 12 months post-implant
measure: Relative Risk of All-cause Events
timeFrame: 12 months post-implant
measure: Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.
timeFrame: 12 months post implant
measure: Characterize Health Resource Utilization
timeFrame: 12 months post implant
measure: Characterize Randomized Days Alive Out of Hospital
timeFrame: 12 months post implant
measure: Characterize Subject Survival
timeFrame: 12 months post implant
measure: Characterize Medication Usage
timeFrame: 12 months post implant
measure: Characterize Intracardiac Pressure
timeFrame: 12 months post implant
measure: Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events
timeFrame: 12 months post implant
measure: Characterize NYHA Functional Class
timeFrame: baseline to 12 months post implant
measure: Characterize Distance Walked in Six Minutes
timeFrame: baseline to 12 months post implant
measure: Characterize Renal Function at the Baseline and 12-month Visit
timeFrame: baseline to 12 months post implant
measure: Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)
timeFrame: implant
measure: Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)
timeFrame: Implant
measure: Characterize Quality of Life at Baseline and 12-month Visit
timeFrame: baseline to 12 months post implant
measure: Characterize Arrhythmic Events
timeFrame: 12 months post implant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: LaJolla
country: United States
facility: Scripps Green Hospital
state: California
city: LA
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial
state: California
city: Modesto
country: United States
facility: Doctors Medical Center Modesto
state: California
city: New Haven
country: United States
facility: Yale University, School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Gainesville
country: United States
facility: University of FL Shands
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Crawford Long/Emory University Hospitals
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Davenport
country: United States
facility: Genesis Hospital Midwest Cardiovascular Research Foundation
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital Metropolitan Cardiology Consultants
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Mid America Heart Institute/St. Lukes
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York City
country: United States
facility: Mt Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital Mid Carolinas Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Heart Specialists
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Heart & Stroke Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional
state: South Carolina
city: Nashville
country: United States
facility: Baptist Hospital
state: Tennessee
city: Nashville
country: United States
facility: St Thomas
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: Oklahoma Heart Hospital
name: Phillip Adamson, MD
role: STUDY_CHAIR
affiliation: Medical University of South Carolina
name: Michael Gold, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.