Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Karolinska Institutet
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Quality of life
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.
Detailed Description
Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.
Investigators
Thomas Kahan
Professor
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •Patients 60 years of age or older
- •Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV
- •Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography
Exclusion Criteria
- •An acute myocardial infarction or unstable angina pectoris within the last three months
- •Valvular stenosis
- •Severe concomitant disease
- •Refusal to participate.
Outcomes
Primary Outcomes
Quality of life
Time Frame: 18 months
Nottingham health profile used for quality of life assessment
Secondary Outcomes
- Hospitalizations(18 months)
- Evaluation of heart failure medication(18 months)
- Mortality(18 months)