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Metabolic Modulation as Treatment in Acute Heart Failure (MEMO)

Primary Purpose

Acute Heart Failure

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
acipimox
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Acute heart failure, Metabolic modulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Skejby Sygehus, Department of Cardiology

Outcomes

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

Full Information

First Posted
March 19, 2007
Last Updated
October 24, 2007
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00449423
Brief Title
Metabolic Modulation as Treatment in Acute Heart Failure
Acronym
MEMO
Official Title
Metabolic Modulation as Treatment in Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
due to slow recruitment
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Acute heart failure, Metabolic modulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
acipimox
Primary Outcome Measure Information:
Title
Cardiac index
Title
pulmonary Wedge Pressure
Title
Ejection fraction
Secondary Outcome Measure Information:
Title
myocardial glucose- and Free Fatty Acid-extraction
Title
cardiac output
Title
Regional left ventricle function
Title
outcome day 6 and 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads Halbirk, dr.
Organizational Affiliation
Aarhus University Hospital, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby Sygehus, Department of Cardiology
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Metabolic Modulation as Treatment in Acute Heart Failure

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