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Completed

NCT Number: NCT01437371

Is There a Benefit to Optimize Heart Failure (HF) 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

- Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.

Drug

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 outcomes

  1. Change from baseline in quality of life

    Time frame: baseline, at 6 months

Secondary outcomes

  1. Mortality

    Time frame: at 12 months

  2. Rehospitalisation

    Time frame: at 12 months

  3. Cardiovascular events

    Time frame: at 12 months

  4. Cardiac fibrosis

    Time frame: at 12 months

  5. Quality of life

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • LivaNova
  • Servier

Registry information

Official study title

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

Acronym: HF 80

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 20, 2011
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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