Multimodal Approach of Undernutrition in Chronic Heart Failure

Summary

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.

Conditions

• Chronic Heart Failure

Interventions

OTHER

Physical rehabilitation (exercise).

Sponsors & Collaborators

• Durtol clinical center

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Ronan THIBAULT · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• France

Study Locations