Metabolic Modulation as Treatment in Acute Heart Failure (MEMO)

October 24, 2007 updated by: University of Aarhus
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ejection fraction
Cardiac index
pulmonary Wedge Pressure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mads Halbirk, dr., Aarhus University Hospital, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

October 25, 2007

Last Update Submitted That Met QC Criteria

October 24, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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