Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

— ACME  

Official title:

Effect of 4 Weeks Treatment With Acipimox on Left Ventricular Function, Work Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549614
• Other study ID #: 20061218
• Status: Completed
• Phase: N/A
• First received: October 25, 2007
• Last updated: October 6, 2009
• Start date: October 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• EF<40 %

• IHD

• NYHA-class II-III.

Exclusion Criteria:

• pregnancy

• severe renal failure

• new brady- or tachyArrhythmia

• Severe stenotic valvular disease

• myocardial infarction within last 6 weeks

• insulin treated diabetes mellitus

• peptic ulcer

• pregnancy or lactating women

• allergy towards tested medicine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• acipimox
capsule, 250 mg, 4 times daily for 28 days
• placebo
capsule, 250 mg, 4 times daily for 28 days

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Aarhus Universityhospital, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection Fraction		4 weeks	No
Primary	exercise capacity		4 weeks	No
Primary	muscular metabolism		4 weeks	No
Secondary	regional left ventricular function		4 weeks	No
Secondary	insulin resistance		4 weeks	No
Secondary	full body metabolism		4 weeks	No