Metabolic Modulation as Treatment in Acute Heart Failure

Acute Heart Failure Clinical Trial

— MEMO  

Official title:

Metabolic Modulation as Treatment in Acute Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449423
• Other study ID #: 20060810
• Status: Terminated
• Phase: Phase 2
• First received: March 19, 2007
• Last updated: October 24, 2007
• Start date: March 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• acipimox

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby Sygehus, Department of Cardiology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac index
Primary	pulmonary Wedge Pressure
Primary	Ejection fraction
Secondary	myocardial glucose- and Free Fatty Acid-extraction
Secondary	cardiac output
Secondary	Regional left ventricle function
Secondary	outcome day 6 and 30