Optimising Congestive Heart Failure Outpatient Clinic Project

NCT ID: NCT01671995

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2001-06-30

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.

Conditions

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Heart Failure

Keywords

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Heart failure Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nurse monitored heart failure program

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Standard primary health care

Intervention Type PROCEDURE

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

Interventions

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Nurse monitored heart failure program

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

Intervention Type PROCEDURE

Standard primary health care

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Thomas Kahan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnus Edner, MD, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Danderyd University Hospital Corp

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 15310688 (View on PubMed)

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.

Reference Type RESULT
PMID: 12181213 (View on PubMed)

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.

Reference Type RESULT
PMID: 16213040 (View on PubMed)

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.

Reference Type RESULT
PMID: 18338962 (View on PubMed)

Other Identifiers

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OPTIMAL

Identifier Type: -

Identifier Source: org_study_id