Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02892747
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Véronique BENEDYGA, Nutritionist
Phone (0)1 49 81 22 32
Email veronique.benedyga@aphp.fr
Status Recruiting
Phase N/A
Start date September 2016
Completion date November 2020

See also
  Status Clinical Trial Phase
Completed NCT01581008 - Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study N/A
Recruiting NCT06248658 - Assessment of the Impact of Clinical Decision Support Systems Included in Electronic Health Records
Completed NCT02884206 - Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction Phase 3
Enrolling by invitation NCT04790214 - Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon N/A
Completed NCT02807857 - A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care N/A
Active, not recruiting NCT04041193 - An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B) N/A
Completed NCT01546532 - Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF) Phase 2
Completed NCT01197313 - Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers N/A
Completed NCT04225728 - Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study Phase 4