Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients? (HF 80)

September 30, 2014 updated by: University Hospital, Clermont-Ferrand

Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?

The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.

Study Overview

Detailed Description

Aging population, and better management of various heart diseases including ischemic explain the growing up of incidence and prevalence of chronic heart failure. The aging of the population leads now to support services in cardiology and particularly in the units of heart failure in subjects over 80 years. It's a special population with several co-morbidities, in whom it is difficult to introduce all the recommended treatments with optimal doses. There is indeed a significant difference between the optimal doses of treatments tested in studies on heart failure and doses found on the orders of inpatients for HF (heart failure). Unfortunately clinical trials on heart failure have recruited young patients, mean age 65 years. Clinical studies in cardiology and particularly in heart failure recruit young subjects at the expense of seniors who are underrepresented in these studies.

The investigators will compare two groups: the first one with an "optimized" management and the second one as "usual care".

The primary endpoint will evaluate the quality of life at 6 months according to the scale of Minnesota. Secondary outcomes will be the quality of life at 12 months, quality of life measured by the SF 12 (to check what level is most suited to this population) at baseline, 6 months and one year, mortality at 12 months, the number of re-hospitalization and cardiovascular events at 12 months, New York Health Association (NYHA) class (at baseline, 6 months and 12 months) and walking test for 6 minutes (at baseline, 6 months and 12 months). Finally the investigators plan to conduct an analysis on the medical and economic interest of this support.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged over 80 year's old subjects
  • Hospitalized for an acute heart failure
  • Left Ventricle Ejection Fraction ≤ 35%
  • Evaluated life expectancy (Seattle HF score) > 1 year

Exclusion Criteria:

  • Dementia
  • Does not understand French language
  • Followed with an optimized management
  • With reduced mobility
  • Recruited in another clinical trial or in a HF management network
  • AHF with curable aetiology : cardiovascular surgery for CABG or valvular replacement, angioplasty
  • MDRD < 30 ml/min/1.73m²

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: optimized
The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months
The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months
Other: usual care
The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in quality of life
Time Frame: baseline, at 6 months
baseline, at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: at 12 months
at 12 months
Rehospitalisation
Time Frame: at 12 months
at 12 months
Cardiovascular events
Time Frame: at 12 months
at 12 months
Cardiac fibrosis
Time Frame: at 12 months
at 12 months
Quality of life
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Romain ESCHALIER, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (Estimate)

September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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