Phase 4 N=252 Randomized Single-blind Treatment

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Heart Failure · Ventricular Dysfunction, Left

Bottom Line

View on ClinicalTrials.gov: NCT00391846 ↗

Enrolled (actual)

252

Serious AEs

34.5%

Results posted

Jun 2012

Primary outcome: Primary: 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) — 118.6; 128.4 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Captopril (Drug); Enalapril (Drug); Lisinopril (Drug); Ramipril (Drug); Trandolapril (Drug); Bisoprolol (Drug); Carvedilol (Drug); Metoprolol succinate (Drug); Candesartan (Drug); Valsartan (Drug); Eplerenone (Drug); Spironolactone (Drug); Diuretics (Drug); HF treatment according to Swedish guidelines (Drug); Blood samples (Procedure); The Kansas City Cardiomyopathy Questionnaire (KCCQ) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	118.6; 128.4	—
SECONDARY Number of CV Deaths	4; 5	—
SECONDARY Number of Days in Hospital for CV Reason	5.79; 5.94	—
SECONDARY Changes in Heart Failure Symptoms	3.67; 6.11	—
SECONDARY Changes in NT-proBNP Values Over Time in All Patients	2332.1; 2063	—
SECONDARY Changes in Health-related Quality of Life	1.739; 3.172	—
SECONDARY Total Number of Titration Steps in Prescribed Heart Failure Treatment	517; 485	—
SECONDARY Discontinuations	8; 6	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
New York Heart Association(NYHA) class II-IV,
NTproBNP males>800 ng/L, females >1000 ng/L

Exclusion Criteria

Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
Mitral/aortic stenosis,
Patients already receiving optimal HF treatment,
Severe reduction of kidney function

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00391846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.