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

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ClinicalTrials.gov Identifier: NCT00549614
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
University of Aarhus

Brief 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

Condition or disease Intervention/treatment Phase
Heart Failure Drug: acipimox Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. left ventricular ejection Fraction [ Time Frame: 4 weeks ]
  2. exercise capacity [ Time Frame: 4 weeks ]
  3. muscular metabolism [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. regional left ventricular function [ Time Frame: 4 weeks ]
  2. insulin resistance [ Time Frame: 4 weeks ]
  3. full body metabolism [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cand. Med. Mads Halbirk, Department of Cardiology, Aarhus Universityhospital, Skejby
ClinicalTrials.gov Identifier: NCT00549614     History of Changes
Other Study ID Numbers: 20061218
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

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
Lipid Regulating Agents