The influence of Rimonabant induced cannabinoid receptor blocking on the mass and function of the left ventricle in patients with abdominal adiposity - ADIPOHEART

• Conditions: Adiposity is another risk factor for developing cardiac insufficiency and myocardial hypertrophy. Probably the volume loading of the left ventricle, systemic inflammation, the fatty degeneration of the heart, and mycardial insulin resistance are involved in the pathogenesis of adiposity-associated heart insufficiency. Because Rimonabant reduces the body weight and improves the above-named symptoms it may prevent heart insufficiency and cardiac arrhythmia in adipose patients.

• Registration Number: EUCTR2007-001787-71-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• abdominal adiposity (waist circumference >102 cm men, >88 cm women)
• blood pressure <140/90 mm Hg
• age 18-60 years
• possibility to discontinue concomitant medication during treatment with the study
drug
• women of childbearing potential with adequate contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• body mass index <28 or >40 kg/m2
• weight >130kg
• increase in body weight >2 kg in the run-in phase
• changes in body weight >2 kg within 3 month prior to study start; history of
surgical reduction of body weight
• Diabetes mellitus Type 1 or 2
• familiar alterations of metabolism
• hepatic disease, Cholestase (transaminases or gamma-GT increased more than 2-
fold)
• symptomatic or detected coronary heart disease, myocardial infarct
• heart insufficiency NYHA II-IV
• symptomatic/detected valvular defect
• symptomatic or detected peripheral arterial occlusive disease
• atherosclerosis der hirnversorgenden Arterien, TIA or apoplexia
• renal insufficiency or serum creatinine above the normal range
• sleep apnoea
• coagulation disorder or intake of oral anticoagulants
• contraindication to do cardiac MRTs: pacemaker or other metal implantations, atrial
fibrillation
• disease or operation effecting drug resorption
• pregnancy or breastfeeding
• autoimmune disease; organ transplantation; History of malignancy and chronic
diseases
• history of alcohol or drug abuse, or both; psychiatric disorder
• history of treated or untreated depressive phases
• intake of antidepressants or drugs to reduce the body weight during the last year prior to study start
• Participation in another investigational drug trial within the eight weeks prior to study entry
• incompatibility to Rimonabant or ingredients of the study drug
• incompatibility to Lidocain
• patients with epilepsy or anamnestischen Krampfanfällen
• patients with hereditary galactose intolerance, lactase deficiency or glucose-
galactose malabsorption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Absolute change of the mass of the left ventricle after 36 weeks treatment with Rimonabant compared with placebo;Secondary Objective: - absolute and relative changes of the mass of the left ventricle within the two study groups<br>- changes in the diameter and volume of the left ventricle<br>- changes in the function, in the cardiac output per minute, in the systolic stress, and the systemic vascular resistance<br>-changes in the amount of pericardial fatty tissue compared to the abdominal and intra hepatic fatty tissue;Primary end point(s): Absolute change of the mass of the left ventricle after 36 weeks treatment with Rimonabant compared with placebo