NT-proBNP Stratified Follow-Up in Outpatient Heart Failure Clinics - NorthStar

Description:

The goal of the trial was to evaluate a strategy of heart failure clinic management versus general practice management among heart failure patients.

Hypothesis:

Heart failure clinic management would result in superior outcomes.

Study Design

  • Randomized
  • Blinded
  • Parallel
  • Stratified

Patient Populations:

  • Patients with clinically stable systolic heart failure on optimal therapy

    Number of screened applicants: 1,628
    Number of enrollees: 1,120
    Duration of follow-up: 6 months
    Mean patient age: 68 years
    Percentage female: 23%
    Ejection fraction: 32%

Primary Endpoints:

  • Time to death or heart failure hospitalization

Drug/Procedures Used:

Patients with clinically stable systolic heart failure were randomized to one of three arms: 1) heart failure clinic management (n = 461), 2) heart failure clinic management with N-terminal portion of B-type natriuretic peptide (NT-proBNP) guided therapy (n = 199), or 3) general practice management (n = 460).

In the NT-proBNP guided therapy group, if the NT-proBNP increased >30% over baseline, practitioners would institute a 14-point checklist in an attempt to improve heart failure management.

Concomitant Medications:

At baseline in the heart failure management group, the use of angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers was 86%, beta-blockers was 84%, and aldosterone antagonists was 31%.

Principal Findings:

Overall, 1,120 patients were randomized. In the heart failure management group, the mean age was 68 years, 23% were women, mean left ventricular ejection fraction was 32%, and mean NT-proBNP was 793 pg/ml.

Time to death or cardiovascular hospitalization was similar with management in the heart failure clinic compared with management in general practice (hazard ratio [HR] 1.17, p = 0.15) and was also similar with unguided heart failure clinic management compared with heart failure clinic management guided by NT-proBNP (HR 0.95, p = 0.78).

Interpretation:

Among patients with clinically stable systolic heart failure on optimal heart failure medications, similar outcomes were observed by managing patients in a heart failure clinic versus a general medical clinic. Also, patients managed within the heart failure clinic did not have improved outcomes when guided by NT-proBNP levels.

The COMPASS-HF trial also studied advanced heart failure patients on optimal medical therapy and was unable to demonstrate a benefit from an implantable device for continuous hemodynamic monitoring.

References:

Presented by Dr. Morten Schou at the ACC.11/i2 Summit, New Orleans, LA, April 5, 2011.

Clinical Topics: Anticoagulation Management, Heart Failure and Cardiomyopathies, Acute Heart Failure, Chronic Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: Follow-Up Studies, General Practice, Peptide Fragments, Psychotherapy, Group, Stroke Volume, Heart Failure, Systolic, Checklist, Natriuretic Peptide, Brain


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