Faculty Collaboration Database

Design and methods of the Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study. Am Heart J 2010 Apr;159(4):532-538.e1

Date

04/07/2010

Pubmed ID

20362709

DOI

10.1016/j.ahj.2010.01.005

Scopus ID

2-s2.0-77950155042 (requires institutional sign-in at Scopus site)   60 Citations

Abstract

BACKGROUND: Serial measurements of N-terminal pro-B type natriuretic peptide (NT-proBNP) provide prognostic information in patients with chronic heart failure (HF). Changes in NT-proBNP concentrations parallel prognosis; however, it remains unclear whether HF care with a goal to maximize medical therapy and also lower NT-proBNP concentrations is superior to standard HF care alone.

AIMS: The aim of the study was to evaluate the hypothesis that an HF strategy guided by NT-proBNP reduces cardiovascular events compared to standard of care HF management.

METHODS: In a prospective randomized single-center trial, subjects with New York Heart Association class II to IV systolic HF (left ventricular ejection fraction < or =40%) will be enrolled. Both groups will receive standard HF management (with a goal for minimizing HF symptoms and achieving maximal dosages of therapies with proven mortality benefit in HF), whereas one group ("NT-proBNP") will also have treatment adjustments to reduce NT-proBNP concentrations < or =1,000 pg/mL. The primary end point of the trial is total cardiovascular events for a 1-year period; secondary end points will include effects of NT-proBNP-guided care on cardiac structure and function, quality of life, and total costs of care.

RESULTS: Enrollment began in 2006; of the original 300 planned, thus far, 151 subjects have been randomized. Interim analysis in November 2009 indicated significant reduction of events in the NT-proBNP arm. Full results are expected in 2010.

CONCLUSIONS: The Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study will test the hypothesis that therapy guided by NT-proBNP concentrations will be superior to standard of care HF management (www.clinicaltrials.gov identifier NCT00351390).

Author List

Bhardwaj A, Rehman SU, Mohammed A, Baggish AL, Moore SA, Januzzi JL Jr

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Female
Heart Failure
Humans
Male
Middle Aged
Natriuretic Peptide, Brain
Peptide Fragments
Severity of Illness Index
Treatment Outcome