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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
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • left ventricular ejection Fraction [ Time Frame: 4 weeks ]
  • exercise capacity [ Time Frame: 4 weeks ]
  • muscular metabolism [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • regional left ventricular function [ Time Frame: 4 weeks ]
  • insulin resistance [ Time Frame: 4 weeks ]
  • full body metabolism [ Time Frame: 4 weeks ]

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 27, 2017