Multimodal Approach of Undernutrition in Chronic Heart Failure (NUTRICARD)
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|ClinicalTrials.gov Identifier: NCT01864733|
Recruitment Status : Unknown
Verified May 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was: Not yet recruiting
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an independent risk factor for mortality and complications. Up-to-date, interventional studies involving nutrition are scarce in CHF. Academic societies are recommending the use of oral nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS could improve nutritional status in undernourished CHF patients, but solely administered, have a limited impact on undernutrition, physical performance and prognosis. A multimodal approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the clinical benefits of such an approach in patients with chronic respiratory insufficiency (CRI), who have similar nutritional and muscular characteristics.
Exercise rehabilitation is well validated in CHF patients, but has never been validated in case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality of life and cardiovascular outcomes including mortality.
N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be useful for CHF patients rehabilitation.
Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly muscle strength, walking endurance and quality of life. In the context of a multimodal approach, Androgen substitution together with exercise rehabilitation and ONS could have a beneficial effect on muscle mass, strength and endurance of CHF patients, as already described in CRI, elderly and HIV patients.
The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF patients.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Other: Physical rehabilitation (exercise).||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multimodal Approach of Undernutrition in Chronic Heart Failure : a Controlled, Randomized Trial|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
Experimental: intervention group
1) The 'intervention' group: 3-month multimodal approach associating exercise rehabilitation, ONS, n-3 PUFAs and androgen substitution:
Other: Physical rehabilitation (exercise).
2) The 'control' group: no multimodal approach but the treatment currently recommended: heart rehabilitation and dietary counseling during 3 months.
Other: Physical rehabilitation (exercise).
- ventilatory workload VO2 [ Time Frame: 3 months ]
- Heart function (to measure left ventricle fraction) [ Time Frame: at 3 months ]
- Heart function (clinical exam) [ Time Frame: at 6 months ]
- Heart function (plasma NT pro-Brain Natriuretic Peptide) [ Time Frame: at 3 months ]
- Plasma NT pro-Brain Natriuretic Peptide (Nt ProBNP) [ Time Frame: at 3 months and at 6 months ]
- Maximal cycle exercise capacity test coupled with respiratory exchanges: VO2 peak, peak workload on bicycle, endurance time between peak and ventilatory workload [ Time Frame: at 3 months ]
- Quadriceps strength [ Time Frame: at 3 months ]
- 6-min walking test [ Time Frame: at 3 months ]
- Nutritional status (weight, height, body mass index) [ Time Frame: before intervention and at 3 months and 6 months ]
- Quality of life with specific questionnaires [ Time Frame: before intervention and at 3 months and 6 months ]
- Hospital stays (number of days) [ Time Frame: at 12 months and at 15 months ]
- Body composition (weight, height, body mass index) [ Time Frame: at month 3 and month 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864733
|Contact: Patrick LACARINfirstname.lastname@example.org|
|CHU Clermont-Ferrand||Not yet recruiting|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04.73.75.11.95 email@example.com|
|Principal Investigator:||Ronan THIBAULT||University Hospital, Clermont-Ferrand|