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

NCT ID: NCT00549614

Last Updated: 2009-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

acipimox

Intervention Type DRUG

capsule, 250 mg, 4 times daily for 28 days

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsule, 250 mg, 4 times daily for 28 days

Interventions

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acipimox

capsule, 250 mg, 4 times daily for 28 days

Intervention Type DRUG

placebo

capsule, 250 mg, 4 times daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Department of Cardiology, Aarhus Universityhospital, Skejby

Principal Investigators

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Mads Halbirk

Role: PRINCIPAL_INVESTIGATOR

B-research, Aarhus Universityhospital, skejby

Locations

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Department of Cardiology, Aarhus Universityhospital, Skejby

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20061218

Identifier Type: -

Identifier Source: org_study_id

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