CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 152 enrolled
Drug / intervention
Drug therapy for HF +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00351390
NCT00351390N/ACompleted

The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study

Massachusetts General Hospital·interventional·Posted Jul 12, 2006·Updated Mar 25, 2019

In Brief

A clinical study evaluating Drug therapy for HF and NT-proBNP guided HF therapy for Congestive Heart Failure. Completed, enrolled 152 participants across 1 site.

Detailed Summary

Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability. It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values. The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2006
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.0 years ago

Interventions

Drug therapy for HFother

Titration of HF meds in an aggressive out patient manner following guideline direction

NT-proBNP guided HF therapyother

Standard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP \<1000 pg/mL