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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
acipimox
placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Aarhus Universityhospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

left ventricular ejection Fraction
exercise capacity
muscular metabolism

Secondary Outcome Measures

regional left ventricular function
insulin resistance
full body metabolism

Full Information

First Posted
October 25, 2007
Last Updated
October 6, 2009
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00549614
Brief Title
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
acipimox
Intervention Description
capsule, 250 mg, 4 times daily for 28 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsule, 250 mg, 4 times daily for 28 days
Primary Outcome Measure Information:
Title
left ventricular ejection Fraction
Time Frame
4 weeks
Title
exercise capacity
Time Frame
4 weeks
Title
muscular metabolism
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
regional left ventricular function
Time Frame
4 weeks
Title
insulin resistance
Time Frame
4 weeks
Title
full body metabolism
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads Halbirk
Organizational Affiliation
B-research, Aarhus Universityhospital, skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Aarhus Universityhospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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

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