Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients?
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril. (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s):
Romain ESCHALIER, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
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.
Clinical Details
Official title: Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in quality of life
Secondary outcome: MortalityRehospitalisation Cardiovascular events Cardiac fibrosis Quality of life
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France
Additional Information
Starting date: August 2011
Last updated: September 30, 2014
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