Metabolic Modulation as Treatment in Acute Heart Failure

NCT ID: NCT00449423

Last Updated: 2007-10-25

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-10-31

Brief Summary

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The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

Detailed Description

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Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.

Conditions

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Acute Heart Failure

Keywords

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Acute heart failure Metabolic modulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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acipimox

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute heart failure
* NYHA class III - IV.
* ejection fraction \<35

Exclusion Criteria

* Age \<18 år or \>85 år,
* allergy
* renal failure
* recently developed brady- or tachy-arrythmias
* Serious infection
* Heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease
* Recent Myocardial infarction (\<6 Weeks)
* Pulmonary Wedge pressure \>30 mm Hg
* diabetes mellitus treated with insulin
* peptic ulcer
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Mads Halbirk, dr.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Department of Cardiology

Locations

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Aarhus University Hospital, Skejby Sygehus, Department of Cardiology

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20060810

Identifier Type: -

Identifier Source: org_study_id