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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
- Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Aged and over 80, clinical trial, quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

optimized

usual care

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in quality of life

Secondary Outcome Measures

Mortality
Rehospitalisation
Cardiovascular events
Cardiac fibrosis
Quality of life

Full Information

First Posted
August 31, 2011
Last Updated
September 30, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Servier, LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT01437371
Brief Title
Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients?
Acronym
HF 80
Official Title
Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Servier, LivaNova

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Aged and over 80, clinical trial, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
optimized
Arm Type
Other
Arm Description
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
Arm Title
usual care
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
- Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in quality of life
Time Frame
baseline, at 6 months
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
at 12 months
Title
Rehospitalisation
Time Frame
at 12 months
Title
Cardiovascular events
Time Frame
at 12 months
Title
Cardiac fibrosis
Time Frame
at 12 months
Title
Quality of life
Time Frame
at 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain ESCHALIER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22394464
Citation
Eschalier R, Jean F, Pereira B, Monzy S, Vorilhon C, Mactoux V, Citron B, Sapin V, Motreff P, Lusson JR. Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial. Trials. 2012 Mar 6;13:25. doi: 10.1186/1745-6215-13-25.
Results Reference
derived

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

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