Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure; Ventricular Dysfunction, Left
Intervention: 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)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): AstraZeneca Sweden Medical Director, MD, Study Director, Affiliation: AstraZeneca Hans Persson, MD, PhD, Principal Investigator, Affiliation: Danderyd Hospital, Sweden Bjorn Eriksson, MD, Study Director, Affiliation: AstraZeneca
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: Number of CV DeathsNumber of Days in Hospital for CV Reason Changes in Heart Failure Symptoms Changes in NT-proBNP Values Over Time in All Patients Changes in Health-related Quality of Life Total Number of Titration Steps in Prescribed Heart Failure Treatment Discontinuations
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Alvesta, Sweden
Research Site, Arvika, Sweden
Research Site, Bjuv, Sweden
Research Site, Borensberg, Sweden
Research Site, Bromma, Sweden
Research Site, Dalby, Sweden
Research Site, Eskilstuna, Sweden
Research Site, Gagnef, Sweden
Research Site, Goeteborg, Sweden
Research Site, Hisings Karra, Sweden
Research Site, Huddinge, Sweden
Research Site, Huskvarna, Sweden
Research Site, Joenkoeping, Sweden
Research Site, Kalmar, Sweden
Research Site, Kungalv, Sweden
Research Site, Lerum, Sweden
Research Site, Lessebo, Sweden
Research Site, Lidkoping, Sweden
Research Site, Lilla Edet, Sweden
Research Site, Linkoeping, Sweden
Research Site, Ludvika, Sweden
Research Site, Lyckeby, Sweden
Research Site, Malmo, Sweden
Research Site, Moheda, Sweden
Research Site, Motala, Sweden
Research Site, Orebro, Sweden
Research Site, Ostersund, Sweden
Research Site, Skanor, Sweden
Research Site, Soderakra, Sweden
Research Site, Stenungsund, Sweden
Research Site, Stocksund, Sweden
Research Site, Timra, Sweden
Research Site, Uddevalla, Sweden
Research Site, Ulricehamn, Sweden
Research Site, Umea, Sweden
Research Site, Uppsala, Sweden
Research Site, Vasteras, Sweden
Research Site, Vastervik, Sweden
Research Site, Vaxjo, Sweden
Additional Information
Starting date: October 2006
Last updated: June 18, 2012
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