Optimising Congestive Heart Failure Outpatient Clinic Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Nurse monitored heart failure program
* Procedure: Standard primary health care


Participation Criteria
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Eligibility Criteria
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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 Dementia Severe concomitant disease Refusal to participate.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse monitored heart failure program<br>To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care. | Procedure: Nurse monitored heart failure program<br>* Standard program for a heart failure clinic with information, education, drug titration<br>|
| Active Comparator: Standard primary health care<br>To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care. | Procedure: Standard primary health care<br>* Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Nottingham health profile used for quality of life assessment | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | Registry data that cover all hospitalizations for all patients | 18 months | 
| Evaluation of heart failure medication | Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication | 18 months | 
| Mortality | Mortality from death certificates obtained. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Quality of life