Clinical trial NCT00852020: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
Official title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia
Chronic Obstructive Pulmonary Disease
Chronic Heart Failure
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* diagnosis of CHF or COPD
* current body weight less than 6 months ago
* BMI \>=20 and \<=30 kg/m2
* CHF: LVEF \>=45% measured within the past 6 months
* symptom status equivalent to NYHA class II to IV
* biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
* on standard therapy of CHF including ACE inhibitors and beta blockers
* COPD: symptom status equivalent to GOLD standard class II to IV
* FEV1 \< 80%
* FEV1/FEV \< 70%

Exclusion Criteria:

* significant oedema in the time of screening and randomisation
* concomitant inflammatory diseases
* active infections including HIV and AIDS
* liver failure
* chronic renal failure (sCr\>1.5mg/dL) or cardiac pacemaker
* acute or chronic infections
* insulin treated diabetes mellitus
* patient with established diagnosis of cachexia
* life expectancy of less than 6 months in the opinion of the investigator
* medications that impair sex hormone synthesis, secretion or function
* patients with psychiatric diseases
* body weight loss \> 5% during the last 6 months or \> 10% during the last 10 months
* suspected allergy to any component of the investigational product(s)
* fish oil supplementation within 3 months prior to the study entry
* taking vitamin supplements in doses greater than the Recommended Daily Allowances

Primary outcomes:
measure: compliance to nutrition therapy
timeFrame: baseline, months 1, 2, 3, 4
Secondary outcomes:
measure: anorexia questionnaire
timeFrame: baseline, months 1, 2, 3, 4
measure: Gastrointestinal syndrome score (GIS)
timeFrame: baseline, months 1, 2, 3, 4
measure: body cell mass
timeFrame: baseline, months 1, 2, 3, 4
measure: weight change
timeFrame: baseline, months 1, 2, 3, 4
measure: hand grip strength
timeFrame: baseline, months 1, 2, 3, 4
measure: patient global assessment (PGA)
timeFrame: baseline, months 2, 4
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
city: Schwedt/Oder
country: Germany
facility: Praxis für Pneumologie, Schwedt/Oder
city: Piekary Śląskie
country: Poland
facility: Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
city: Ruda Śląska
country: Poland
facility: Specjalista Chorób Wewnętrznych Kardiolog
Study officials:
affiliation: Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
name: Stefan Anker, Prof. MD PHD
role: PRINCIPAL_INVESTIGATOR
References: