Multimodal Approach of Undernutrition in Chronic Heart Failure

NCT01864733 | Unknown

• 2 other identifiers: CHU-01522012-A00632-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic heart failure; Undernutrition; Rehabilitation; Physical exercise; Nutrition; n-3 fatty acids; Androgen; Testosterone

Outcome Measures

Primary Outcomes (1)

• ventilatory workload VO2

  3 months

Secondary Outcomes (11)

• Heart function (to measure left ventricle fraction)

  at 3 months

• Heart function (clinical exam)

  at 6 months

• Heart function (plasma NT pro-Brain Natriuretic Peptide)

  at 3 months

• Plasma NT pro-Brain Natriuretic Peptide (Nt ProBNP)

  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

  at 3 months

Study Arms (2)

intervention group

EXPERIMENTAL

1\) The 'intervention' group: 3-month multimodal approach associating exercise rehabilitation, ONS, n-3 PUFAs and androgen substitution: * Physical rehabilitation including endurance and resistance exercises two to three times a week. * Oral nutritional supplements: Fortimel max® (Nutricia®) (300 ml, 720 kcal, 29 g de proteins), once per day. * n-3 polyunsaturated fatty acids : DHA phospholipids (GPL-DHA®), 240 mg/day. * Testosterone: Testopatch® 2.4 mg in men and 1.2 mg in women; 2 patches renewed every two days.

Other: Physical rehabilitation (exercise).

control group

OTHER

2\) The 'control' group: no multimodal approach but the treatment currently recommended: heart rehabilitation and dietary counseling during 3 months.

Other: Physical rehabilitation (exercise).

Interventions

Physical rehabilitation (exercise). OTHER

control group; intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable patients with CHF, defined by the absence of acute episodes since 2 months, and absence of exercise rehabilitation in the two last months
• NYHA III Heart failure
• VO2 peak \< 18 ml/kg/min
• Left ventricle ejection fraction ≤ 40%
• Age ≥ 18 years, informed, having given their consent
• Absence of acute disease
• Undernutrition, defined by :
• Involuntary weight loss ≥5% during the 12 last months, without any increase of diuretics doses
• or body mass index \<20
• or fat-free mass index assessed by BIA \<18 in men, and \<15 in women.

You may not qualify if:

• Heart failure related to pulmonary hypertension
• Heart failure treatable by surgery or angioplasty
• Patients eligible to ventricular resynchronisation
• Instable heart failure
• Patients waiting for transplantation
• On-going imunosuppressant or corticosteroids
• Disease affecting 6-month survival (end-stage cancer, or chronic disease,…)
• Positive VIH or hepatitis C serology
• Liver failure
• Respiratory insufficiency
• End-stage (stage 5) renal failure (creatinine clearance ≤15ml/kg/min)
• Acute disease
• Previous history of hormonal cancer (breast, prostate)
• Suspected or proved hormonal cancer (breast, prostate)
• Hypersensibility to testosterone or components of testosterone patch

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Durtol clinical center: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• University Hospital, Grenoble: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Malnutrition; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ronan THIBAULT

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04.73.75.11.95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: May 30, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

FR (1)