Status:
COMPLETED
Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting.
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Roche Diagnostics GmbH
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 hospitalizat...
Detailed Description
300 patients with class II-IV heart failure (HF) due to systolic dysfunction (left ventricular ejection fraction \<40%) and recent (within 6 months) destabilized HF will be randomized 1:1 to either 's...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00351390
Start Date
September 1 2005
End Date
June 1 2009
Last Update
March 25 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02467