NCT01671995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 1996

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

5.4 years

First QC Date

August 19, 2012

Last Update Submit

August 21, 2012

Conditions

Heart Failure

Keywords

Heart failureQuality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Nottingham health profile used for quality of life assessment

    18 months

Secondary Outcomes (3)

  • Hospitalizations

    18 months

  • Evaluation of heart failure medication

    18 months

  • Mortality

    18 months

Study Arms (2)

Nurse monitored heart failure program

EXPERIMENTAL

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.

Procedure: Nurse monitored heart failure program

Standard primary health care

ACTIVE COMPARATOR

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.

Procedure: Standard primary health care

Interventions

Nurse monitored heart failure programPROCEDURE

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

Nurse monitored heart failure program
Standard primary health carePROCEDURE

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

Standard primary health care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • An acute myocardial infarction or unstable angina pectoris within the last three months
  • Valvular stenosis
  • Dementia
  • Severe concomitant disease
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd University Hospital Corp

Stockholm, 182 88, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 15310688RESULT

  • 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.

    PMID: 12181213RESULT

  • 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.

    PMID: 16213040RESULT

  • 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.

    PMID: 18338962RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Magnus Edner, MD, PhD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2012

First Posted

August 24, 2012

Study Start

January 1, 1996

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

SE(1)