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Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol
Romain Eschalier1, Frédéric Jean, Bruno Pereira
1CHU Clermont-Ferrand, Service Cardiology, F-63000 Clermont-Ferrand. reschalier@chu-clermontferrand.fr
Insights
This study investigates optimizing heart failure treatment for patients over 80. It aims to determine if guideline-adherent care improves quality of life and other outcomes in this elderly population.
Area of Science:
- Gerontology
- Cardiology
- Clinical Trials
Background:
- Chronic heart failure (HF) is increasing in prevalence due to an aging population and improved disease management.
- Current HF guidelines are applied to elderly patients (>80 years), but clinical trial data supporting their benefit in this group is lacking.
- Registries indicate under-prescription of HF treatments in elderly and over-80 populations.
Purpose of the Study:
- To evaluate the effect of optimizing heart failure management by adhering to international guidelines in patients over 80 years old.
- To assess the impact of guideline-based care on quality of life, mortality, hospital readmissions, cardiac fibrosis, and economic data in elderly HF patients.
Main Methods:
- Prospective, randomized, open-label clinical trial with blinded endpoints (HF-80 study).
- Inclusion of 80 patients aged over 80 admitted with acute heart failure.
- Comparison of usual care (Group A) versus optimized guideline-adherent management (Group B).
Main Results:
- Primary endpoint: Quality of life assessed using the Minnesota questionnaire at 6 months.
- Secondary endpoints: Quality of life, mortality, HF readmissions, cardiac fibrosis, and economic data assessed at 12 months.
Conclusions:
- Assessing the benefit of guideline-based heart failure management in the over-80 population is crucial due to their fragility.
- There is a high risk of iatrogenic complications in this demographic, necessitating careful evaluation of treatment strategies.
Background:
An aging population and better management of various heart diseases explain the exponential growth in incidence and prevalence of chronic heart failure, with poor prognosis and heavy health costs. Medical management is codified in international guidelines. The management of heart failure in over-80 year-old patients follows these guidelines, but no clinical trials have been able to confirm benefit. Moreover, registries show down-prescription of heart failure treatments in the elderly and over-80s.
Methods/Design:
We present the design of the HF-80 ("Is there benefit in optimising heart failure treatment in over-80 year-old patients?") study, which is a prospective randomised open-label clinical trial with blinded end-points, designed to evaluate the effect of optimising management by adhering to guidelines in over-80 year-old heart failure patients. Patients over 80 years of age admitted with acute heart failure will be included. The primary endpoint is to assess quality of life at 6 months on the Minnesota questionnaire. The secondary endpoints are to assess the effect of optimised management on quality of life, mortality, readmission for acute heart failure, cardiac fibrosis and economic data at 12 months. 80 patients will be included, divided into 2 groups: group A, with usual heart failure management by general practitioners; and group B, with optimised management based on international guidelines.
Discussion:
It is necessary to assess the benefit of guidelines in over-80 year-old heart failure patients because of the fragility of this population and the elevated risk of iatrogenic complications.
Trial Registration:
Clinical trials.gov number: NCT01437371.
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