Skip to content

Randomised clinical trial to assess the efficacy of a multifactorial intervention in order to reduce hospitalisation and improve quality of life in patients with heart failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35096435
Enrollment
400
Registered
2005-02-01
Start date
2004-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Heart Failure Circulatory System Heart failure

Interventions

A multidisciplinary approach to patient education and counselling, optimisation of the treatments (drugs, diet, exercise), monitorisation of the electrolyte concentrations if necessary, and teaching e

Sponsors

Sardenya Primary Care Center (Spain) - in collaboration with the Catalan Foundation Institute of Pharmacology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 400 patients recruited from four hospitals in Catalonia: Vall d?Hebron Hospital, Clínic Hospital, Dos de Maig Hospital and Vic Hospital. Inclusion Criteria: Males and females without any limit of age, discharged from the hospital with the diagnosis of heart failure following the criteria of the European Society of Cardiology.

Exclusion criteria

Exclusion criteria: 1. Patients with heart failure due to reversible causes (hyperthyroidism, tachyarrhythmia, valve disease candidate for surgery) 2. Patients with concomitant chronic disease (cancer, chronic renal failure etc.) 3. Patients with poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study

Design outcomes

Primary

MeasureTime frame
The combination of cardiovascular mortality and rehospitalisations (emergency room and/or hospital) at one year.

Secondary

MeasureTime frame
1. Total mortality or rehospitalisation for any reason 2. Rehospitalisation due to heart failure 3. Time until rehospitalisation 4. Days of hospitalisation 5. Quality of life related to health Statistical models to be used will be survival analysis and Cox regression.

Countries

Spain

Outcome results

None listed

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