See also:
All heart failure clinical trials
All clinical trials of BNP guided management
All clinical trials of BNP-guided management
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PROTECT study, 2009
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[NCT00351390]
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Treatments
| Studied treatment |
natriuretic-peptide-guided therapy
drug therapy titrated to achieve NT-proBNP <1000 pg/mL
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| Control treatment |
standard management
state-of-the art medical therapy, with device therapy at the physician's discretion, with adjustments to treatment based as usual on clinical judgment
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Patients
| Patients |
patients with NYHA class 2-4 heart failure, LVEF <40%, and history of at least one admission or outpatient diuretic dose increase for heart-failure destabilization in the previous six months |
| Inclusion criteria |
Age > 21 years of age Left ventricular ejection fraction ˇÜ 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 criteria |
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 |
Method and design
| Randomized effectives |
NA / NA (studied vs. control) |
| Design |
Parallel groups |
| Number of centre |
single center |
| Primary endpoint |
worsening HF, HF hospitalization, CV death |
Results
No results available for this trial
- no clinical endpoint reported
Reference(s)
External links about this trial
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