A randomised, parallel group, single blind, multicentre, 9-month, phase IV study in a primary care setting, 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 and left ventricular systolic dysfunction. - SIGNAL HF

• Conditions: Heart Failure

• Registration Number: EUCTR2006-001259-36-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Provision of informed consent.
2. Female or male, aged 18 years and over
3. Diagnosis of heart failure with previously verified left ventricular systolic dysfunction, stated as at least mildly impaired and/or ejection fraction (EF) < 50%.
4. NYHA class II-IV
5. Plasma NT-proBNP: males >800 ng/L, females >1000 ng/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Planned CV hospitalisation (eg cardiac surgery) within the study period.
2. Stroke, acute myocardial infarction or open heart surgery within the last 3 months before enrolment.
3. Mitral stenosis, aortic stenosis of clinical significance.
4. Patients already receiving optimal heart failure treatment according to the national guidelines.
5 Pregnancy or lactation.
6. Severe medical condition, other than disease under investigation, with life expectancy less than 9 months.
7. Severe reduction of kidney function, serum-creatinine >265 umol/L.
8. Suspected poor capability to follow instructions of the study
9. Previous participation in the present study
10. Participation in a clinical study during the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified