Optimising Congestive Heart Failure Outpatient Clinic Project

Overview

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.

Full Title of Study: “Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2001

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.

Interventions

  • Procedure: Nurse monitored heart failure program
    • Standard program for a heart failure clinic with information, education, drug titration
  • Procedure: Standard primary health care
    • Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver

Arms, Groups and Cohorts

  • Experimental: Nurse monitored heart failure program
    • 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.
  • Active Comparator: Standard primary health care
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life
    • Time Frame: 18 months
    • Nottingham health profile used for quality of life assessment

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • Region Stockholm
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas Kahan, Professor – Karolinska Institutet
  • Overall Official(s)
    • Magnus Edner, MD, PhD, Study Chair, Karolinska Institutet

Citations Reporting on Results

Mejhert M, Kahan T, Persson H, Edner M. Limited long term effects of a management programme for heart failure. Heart. 2004 Sep;90(9):1010-5.

Mejhert M, Linder-Klingsell E, Edner M, Kahan T, Persson H. Ventilatory variables are strong prognostic markers in elderly patients with heart failure. Heart. 2002 Sep;88(3):239-43.

Mejhert M, Kahan T, Persson H, Edner M. Predicting readmissions and cardiovascular events in heart failure patients. Int J Cardiol. 2006 Apr 28;109(1):108-13. Epub 2005 Oct 5.

Mejhert M, Kahan T, Edner M, Persson HE. Sex differences in systolic heart failure in the elderly: the prognostic importance of left ventricular mass in women. J Womens Health (Larchmt). 2008 Apr;17(3):373-81. doi: 10.1089/jwh.2007.0487.

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