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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
Sponsor:
Collaborators:
Durtol clinical center
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Grenoble
University Hospital, Geneva
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Chronic Heart Failure Other: Physical rehabilitation (exercise). Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group

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



Primary Outcome Measures :
  1. ventilatory workload VO2 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Heart function (to measure left ventricle fraction) [ Time Frame: at 3 months ]
  2. Heart function (clinical exam) [ Time Frame: at 6 months ]
  3. Heart function (plasma NT pro-Brain Natriuretic Peptide) [ Time Frame: at 3 months ]
  4. Plasma NT pro-Brain Natriuretic Peptide (Nt ProBNP) [ Time Frame: at 3 months and at 6 months ]
  5. 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 ]
  6. Quadriceps strength [ Time Frame: at 3 months ]
  7. 6-min walking test [ Time Frame: at 3 months ]
  8. Nutritional status (weight, height, body mass index) [ Time Frame: before intervention and at 3 months and 6 months ]
  9. Quality of life with specific questionnaires [ Time Frame: before intervention and at 3 months and 6 months ]
  10. Hospital stays (number of days) [ Time Frame: at 12 months and at 15 months ]
  11. Body composition (weight, height, body mass index) [ Time Frame: at month 3 and month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Liver tumor or previous history of liver tumor
  • Unability or contra-indication to rehabilitation program (defined by the French society of Cardiology including contra-indication to physical exercise)
  • Orthopedical limitations to exercise
  • Type 2 diabetes requiring insulin since less than 3 months
  • Patients having not giving their consent

Information from the National Library of Medicine

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


Contacts
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Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04.73.75.11.95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Durtol clinical center
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Grenoble
University Hospital, Geneva
Investigators
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Principal Investigator: Ronan THIBAULT University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01864733     History of Changes
Other Study ID Numbers: CHU-0152
2012-A00632-41
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by University Hospital, Clermont-Ferrand:
Chronic heart failure
Undernutrition
Rehabilitation
Physical exercise
Nutrition
n-3 fatty acids
Androgen
Testosterone
Additional relevant MeSH terms:
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Heart Failure
Malnutrition
Heart Diseases
Cardiovascular Diseases
Nutrition Disorders
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs