Optimising Congestive Heart Failure Outpatient Clinic Project

Heart Failure Clinical Trial

— OPTIMAL  

Official title:

Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671995
• Other study ID #: OPTIMAL
• Status: Completed
• Phase: N/A
• First received: August 19, 2012
• Last updated: August 21, 2012
• Start date: January 1996
• Est. completion date: June 2001

Study information

• Verified date: August 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: June 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Sweden	Danderyd University Hospital Corp	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Nottingham health profile used for quality of life assessment	18 months	No
Secondary	Hospitalizations	Registry data that cover all hospitalizations for all patients	18 months	No
Secondary	Evaluation of heart failure medication	Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication	18 months	No
Secondary	Mortality	Mortality from death certificates obtained.	18 months	No