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

October 6, 2009 updated by: University of Aarhus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Department of Cardiology, Aarhus Universityhospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular ejection Fraction
Time Frame: 4 weeks
4 weeks
exercise capacity
Time Frame: 4 weeks
4 weeks
muscular metabolism
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
regional left ventricular function
Time Frame: 4 weeks
4 weeks
insulin resistance
Time Frame: 4 weeks
4 weeks
full body metabolism
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mads Halbirk, B-research, Aarhus Universityhospital, skejby

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

October 7, 2009

Last Update Submitted That Met QC Criteria

October 6, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20061218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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