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 HF and Left Ventricular Systolic Dysfunction”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: 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
• Procedure: Blood samples
• Procedure: KCCQ Questionnaire

Primary Measures

• The primary variable is a composite endpoint of days alive, days out of hospital and symptoms
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: No

Secondary Measures

• Number of deaths
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: Yes
• Changes in NTproBNP over time amd related to NYHA class
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: No
• Changes in KCCQ (overall, symptom score subset, related to NTproBNP)
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: No
• Changes in HFstatus and vital signs
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: No
• Number of SAEs
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: No
• Number of DAEs
  • Time Frame: Assessed after 9 months of treatment
    Safety Issue?: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Sweden Medical Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00391846

Study ID Number: D2452L00010

ClinicalTrials.gov Identifier: NCT00391846

Health Authority: Sweden: Medical Products Agency