Clinical trial NCT00643279: Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Official title: Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: implantable hemodynamic monitor
Intracardiac pressures
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

After baseline evaluation and verification that entrance criteria were met, all subjects were implanted with a Chronicle IHM and pressure sensor lead. Following successful implantation, subjects were randomized to either the CHRONICLE group or CONTROL group. Subjects randomized to the CHRONICLE group were managed using Chronicle, specifically trended RV and estimated PA pressure, heart rate and activity data, whereas subjects randomized to the CONTROL group were treated conventionally without the use of the Chronicle data. In the case that implantation was not successful, subjects were exited from the study if no procedure related adverse events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.

Subjects remained randomized until their six month clinic visit had been completed. Following the subject's six month visit, clinicians were granted access to the CONTROL subject's trended Chronicle data on the Chronicle website, and subjects were seen in the clinic for a protocol-required visit every six months until exit from the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
timeFrame: Within 6 months post-implant
measure: Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.
timeFrame: Within 6 months post-implant
measure: Rate of Heart Failure-related Hospital Equivalents.
timeFrame: 6 Months post-implant
Secondary outcomes:
measure: Health Care Utilization
timeFrame: 6 Months post-implant
measure: Days Hospitalization Free
timeFrame: 6 Months post-implant
measure: Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"
timeFrame: 6 Months post-implant
measure: Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
timeFrame: 6 Months post-implant
measure: New York Heart Association (NYHA) Class
timeFrame: 6 Months post-implant
measure: Distance Walked During a Six Minute Hall Walk
timeFrame: 6 Months post-implant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gainesville
country: United States
facility: University of Florida - Shands
state: Florida
city: Atlanta
country: United States
facility: Crawford LongHospital
state: Georgia
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Memorial Hospital
state: Indiana
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Saint Paul
country: United States
facility: St. Paul Heart
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian - Columbia
state: New York
city: Chapel Hill
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Associates
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital/Texas Heart
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: The University of Alabama at Birmingham
name: Robert Bourge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zile MR, Adamson PB, Cho YK, Bennett TD, Bourge RC, Aaron MF, Aranda JM Jr, Abraham WT, Stevenson LW, Kueffer FJ. Hemodynamic factors associated with acute decompensated heart failure: part 1--insights into pathophysiology. J Card Fail. 2011 Apr;17(4):282-91. doi: 10.1016/j.cardfail.2011.01.010. Epub 2011 Feb 26.