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