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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001259-36-SE

Enrollment

250

Registered

2006-05-05

Start date

2006-06-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion 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) 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026