- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01437371
Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients? (HF 80)
Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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baseline, at 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: at 12 months
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at 12 months
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Rehospitalisation
Time Frame: at 12 months
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at 12 months
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Cardiovascular events
Time Frame: at 12 months
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at 12 months
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Cardiac fibrosis
Time Frame: at 12 months
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at 12 months
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Quality of life
Time Frame: at 12 months
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at 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Romain ESCHALIER, University Hospital, Clermont-Ferrand
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Protease Inhibitors
- Protective Agents
- Cardiotonic Agents
- Angiotensin-Converting Enzyme Inhibitors
- Enalapril
- Trandolapril
- Ramipril
- Lisinopril
- Captopril
- Enzyme Inhibitors
Other Study ID Numbers
- CHU-0102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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