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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001259-36-SE
• Date of registration: 05/05/2006
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/06/2006
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001259-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

Main Objective: The primary objective is to evaluate if 9 months of heart failure treatment guided by clinical symptoms, signs and NT-proBNP values is more effective to reduce the combination of cardiovascular (CV) death, CV hospitalisation and heart failure symptoms, than treatment guided by clinical symptoms and signs alone, in patients with chronic heart failure.

Secondary Objective: To study if this treatment is more effective to reduce CV death, decrease the number of days in hospital for CV reasons and reduce heart failure symptoms, separately. To study the change in NT-proBNP values over time in all patients, related to different medications used, correlated to NYHA class and correlated to the KCCQ questionnaire. To study the change in health-related quality of life. To study the level of titration and intensified treatment according to the Swedish guidelines as outlined by the Swedish Medical Product Agency (MPA, Läkemedelsverket 2006). To study the change in vital signs, laboratory values, heart failure status, incidence of SAE and discontinuations due to AEs.

Primary end point(s): The primary variable is a composite endpoint of days alive, days out of hospital and the symptom score subset (questions 3,5,7,9) of the KCCQ. Only CV deaths and days spent in hospital for CV reasons contribute to the endpoint.

Secondary ID(s)

D2452L00010