Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting.

Completed · Not applicable

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00351390

Run by

Massachusetts General Hospital

People needed

152

Starts

2005-09-01

Expected to finish

2009-06-01

Last updated by the study team

2019-03-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 21 years of age
• Left ventricular ejection fraction ≤ 40%
• NYHA class II-IV heart failure
• Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

You may not qualify if…

• Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
• Inoperable aortic valvular heart disease
• Life expectancy <1 year due to causes other than HF such as advanced cancer
• Cardiac transplantation or revascularization indicated or expected within 6 months
• Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1S <1 L when diagnosed as standard of care.
• Subject unable or unwilling to provide written informed consent
• Coronary revascularization (PCI or CABG) within the previous 3 months

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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