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Completed

NCT Number: NCT01671995

Optimising Congestive Heart Failure Outpatient Clinic Project

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd University Hospital Corp

Stockholm, 182 88, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse monitored heart failure program

Procedure

Standard program for a heart failure clinic with information, education, drug titration

Standard primary health care

Procedure

Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver

Primary outcomes

  1. Quality of life

    Time frame: 18 months

    Nottingham health profile used for quality of life assessment

Secondary outcomes

  1. Hospitalizations

    Time frame: 18 months

    Registry data that cover all hospitalizations for all patients

  2. 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

  3. Mortality

    Time frame: 18 months

    Mortality from death certificates obtained.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

Acronym: OPTIMAL

Important dates

Study start
1996
Primary completion
2001
Study completion
2001
First posted
Aug 24, 2012
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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