Metabolic Modulation as Treatment in Acute Heart Failure - Full Text View

Metabolic Modulation as Treatment in Acute Heart Failure (MEMO)

This study has been terminated.

( due to slow recruitment )

First Received: March 19, 2007 Last Updated: October 24, 2007 History of Changes

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00449423

Purpose

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

Condition	Intervention	Phase
Acute Heart Failure	Drug: acipimox	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Metabolic Modulation as Treatment in Acute Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Acipimox

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Cardiac index
pulmonary Wedge Pressure
Ejection fraction

Secondary Outcome Measures:

myocardial glucose- and Free Fatty Acid-extraction
cardiac output
Regional left ventricle function
outcome day 6 and 30

Estimated Enrollment:	32
Study Start Date:	March 2007
Study Completion Date:	October 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449423

Locations

Denmark
Aarhus University Hospital, Skejby Sygehus, Department of Cardiology
Aarhus, Denmark, 8200

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Mads Halbirk, dr.

Aarhus University Hospital, Department of Cardiology

More Information

No publications provided

Study ID Numbers:	20060810
Study First Received:	March 19, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00449423 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee

Keywords provided by University of Aarhus:

Acute heart failure
Metabolic modulation

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Acipimox

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 02, 2009