Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

Completed · Not applicable

Conditions studied: Heart Failure

In brief

COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

Key facts

Study ID

NCT00643279

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

277

Starts

2003-03-01

Expected to finish

2013-04-01

Last updated by the study team

2023-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV
• Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation
• Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation

You may not qualify if…

• Subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
• Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted)
• Subjects who are on continuous positive inotropic therapy
• Subjects with known atrial or ventricular septal defects
• Subjects with mechanical right heart valves
• Subjects with stenotic tricuspid or pulmonary valves
• Subjects with a presently implanted non-compatible pacemaker or ICD
• Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
• Subjects with a major cardiovascular event within 3 months prior to baseline evaluation
• Subjects with a severe non-cardiac condition limiting 6 month survival
• Subjects with a primary diagnosis of pulmonary artery hypertension
• Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis
• Subjects enrolled in concurrent studies that may confound the results of this study
• Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• University of Florida - Shands — Gainesville, Florida, United States
• Crawford LongHospital — Atlanta, Georgia, United States
• Prairie Heart Institute — Springfield, Illinois, United States
• Parkview Memorial Hospital — Fort Wayne, Indiana, United States
• New England Medical Center — Boston, Massachusetts, United States
• St. Paul Heart — Saint Paul, Minnesota, United States
• Mid America Heart Institute — Kansas City, Missouri, United States
• Robert Wood Johnson Medical Center — New Brunswick, New Jersey, United States
• Newark Beth Israel — Newark, New Jersey, United States
• New York Presbyterian - Columbia — New York, New York, United States
• Duke University — Chapel Hill, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oklahoma Cardiovascular Associates — Oklahoma City, Oklahoma, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baptist Memorial Hospital — Germantown, Tennessee, United States
• St. Thomas Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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