Chronic Heart Failure (CHF) Clinical Trial
Impact of Dietetics Education Focused on Prevention of Malnutrition, on Reducing Morbidity and Improving Life Quality of Patients With Chronic Heart Failure (CHF): A Randomized Controlled Multicenter Clinical Trial
The intervention tested in this research project aims to reduce the unplanned hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic education program. This new program provides concrete solutions to patients by offering balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational program should improve the dietary behavior of patients and reinforce the importance of dietary guidance in support of the CHF.
Context: The Chronic Heart Failure (CHF) is a major public health problem in terms of
frequency, mortality and costs. The care integrates a low-salt diet to reduce fluid retention
and cardiac decompensation. A large observational study (ODIN) shows the effectiveness of the
Patient's Therapeutic Education program (PTE which provides learning management sodium intake
by the intervention of a dietician, I-CARE) on reducing mortality. But prognosis of CHF
remains serious leading to many hospitalizations. The nutritional status of patients with CHF
is threatened by inadequate energy intake in connection with the low sodium diet and the rest
energetic cost (REC). Malnutrition increases the risk of hospitalization because it causes an
immune deficiency responsible for infections, bones weakness and impaired cognitive function.
Hypotheses: The investigators postulate that an educational diet focusing on prevention of malnutrition would reduce morbidity and improve quality of life for patients with CHF. For this, the investigators propose a new educational method: adding a personalized program monitoring energy and protein intake in addition to managing sodium intake, notably by offering personalized menu ideas and recipes.
Main objective: Demonstrate that a dietetic education program involving the prevention of malnutrition and managing sodium intake is more effective than the usual dietetic education (based only on management of sodium intake) on the frequency of unplanned hospitalizations (all causes ) at 6 months in CHF patients.
Secondary Objectives: Demonstrate the superiority of the dietetic education program involving the prevention of malnutrition and managing sodium intake over the usual dietetic education, by improving the nutritional status, the quality of life, the survival, the adherence to dietary recommendations and the reduction of hospitalizations for cardiac decompensation, the burden associated with low sodium diet and the costs. ;
|Source||Assistance Publique - Hôpitaux de Paris|
|Contact||Véronique BENEDYGA, Nutritionist|
|Phone||(0)1 49 81 22 32|
|Start date||September 2016|
|Completion date||September 2019|