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