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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00549614
First received: October 25, 2007
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
 Drug: acipimox
Drug: placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • left ventricular ejection Fraction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • exercise capacity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • muscular metabolism [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • regional left ventricular function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • insulin resistance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • full body metabolism [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: acipimox
capsule, 250 mg, 4 times daily for 28 days
Placebo Comparator: 2 Drug: placebo
capsule, 250 mg, 4 times daily for 28 days

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549614

Locations
Denmark
Department of Cardiology, Aarhus Universityhospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Mads Halbirk B-research, Aarhus Universityhospital, skejby
  More Information

No publications provided

Responsible Party: Cand. Med. Mads Halbirk, Department of Cardiology, Aarhus Universityhospital, Skejby
ClinicalTrials.gov Identifier: NCT00549614     History of Changes
Other Study ID Numbers: 20061218
Study First Received: October 25, 2007
Last Updated: October 6, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Acipimox
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013