A Randomised, Single Blind, Multicentre, 9-month, Phase IV Study, Comparing Treatment Guided by Clinical Symptoms and Signs and NT-proBNP vs Treatment Guided by Clinical Symptoms and Signs Alone, in Patients With Heart Failure (HF) and Left Ventricular Systolic Dysfunction

NCT00391846 Phase 4 COMPLETED Results posted

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

Details

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	COMPLETED
Enrolment	252
Start date	2006-10
Completion	2009-01

Conditions

• Heart Failure
• Ventricular Dysfunction, Left

Interventions

• Captopril
• Enalapril
• Lisinopril
• Ramipril
• Trandolapril
• Bisoprolol
• Carvedilol
• Metoprolol succinate
• Candesartan
• Valsartan

Primary outcomes

• Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9) — 9 months
  The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented

Countries

Sweden