Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia

NCT00748332 | Terminated Phase 3

• 1 other identifier: API 2007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac cachexia, the main feature of undernutrition in chronic heart failure, usually defined as a weight loss over 6% over 6 months, is a proven factor of morbidity and mortality in this disease. Its pathophysiology is complex, but proinflammatory cytokines seem to play a major role. Omega-3 poly-unsaturated fatty acids, present in fish oil, have proven beneficial in patients with coronary heart disease, due in part to their effects on membranes but also due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6. The aim of this phase III randomized controlled double-blinded study is to assess the effects of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients will be included in each group. The main judgment criterion will be maximum aerobic capacity (VO2 max), which best reflects aerobic capacity that correlates with muscle mass. Anthropometric, biological (nutritional, inflammatory and involved in food intake control), cardiac (functional) and quality of life will also be studied. All analyses will be performed in intention to treat. The investigators expect a significantly higher improvement of VO2 max in the omega-3 group. This study could lead to therapeutic advances in a frequent and severe disease.

Conditions

Cardiac Cachexia

Outcome Measures

Primary Outcomes (1)

• VO2 max (cycle ergometry)

  D0 and after 8 weeks

Secondary Outcomes (1)

• Weight, BMI, body composition (DAX and BIA), muscle function (dynamometers), biology, quality of life, cardiac function (ultra-sound end-systolic ejection fraction, walking perimeter), food intake.

  D0 and after 8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Standard oral nutritional supplement

Dietary Supplement: Fortimel Extra®

2

EXPERIMENTAL

Omega-3-enriched oral nutritional supplement

Dietary Supplement: Fortimel Care®

Interventions

Fortimel Extra® DIETARY_SUPPLEMENT

2 bottles (600 kcal, 40 g proteins) per day

1

Fortimel Care® DIETARY_SUPPLEMENT

Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years
• Weight loss between 6 and 10% during the last six months
• Chronic heart failure with end-systolic ejection fraction ≤ 40% (all stages of the NYHA classification)
• Triple therapy: ß-blockers, ACE inhibitors and diuretics
• Informed consent signed
• Affiliated with the French Sécurité Sociale

You may not qualify if:

• Patent undernutrition: BMI \< 18.5 for ages \< 70 or \< 21 for ages ≥ 70 and/or weight loss \> 10% in the last six months
• Chronic cachectic condition:
• cancer
• chronic respiratory failure
• advanced organ failure
• hyperthyroidism
• rheumatoid arthritis
• AIDS
• type 1 diabetes
• Drugs affecting muscle mass (e.g., steroids)
• Condition (clinical or EKG) contra-indicating cycle ergometry
• Unstable acute disease
• Edema
• Flare-up of heart failure (BNP \> 500 ng/L)
• Intake of omega-3-containing nutritional supplements

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Department of Gastro-entérologie

Nice, 06000, France

Location

Study Officials

• Stéphane Schneider, PU-PH

  Department of Gastroentrology of Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 8, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2012
• Last Updated: August 22, 2012

Record last verified: 2009-06

Locations

FR (1)