Clinical trial NCT01671995: Optimising Congestive Heart Failure Outpatient Clinic Project
Official title: Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Quality of life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-08-24
Enrollment: 208
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Dementia
* Severe concomitant disease
* Refusal to participate.

Primary outcomes:
measure: Quality of life
timeFrame: 18 months
Secondary outcomes:
measure: Hospitalizations
timeFrame: 18 months
measure: Evaluation of heart failure medication
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd University Hospital Corp
Study officials:
affiliation: Karolinska Institutet
name: Magnus Edner, MD, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1136/hrt.2003.014407.
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. doi: 10.1136/heart.88.3.239.
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. doi: 10.1016/j.ijcard.2005.07.015. Epub 2005 Oct 5.
citation: 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.