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Metabolic Modulation as Treatment in Acute Heart Failure

Phase 2
Terminated
Conditions
Acute Heart Failure
Registration Number
NCT00449423
Lead Sponsor
University of Aarhus
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
32
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Cardiac index
pulmonary Wedge Pressure
Ejection fraction
Secondary Outcome Measures
NameTimeMethod
outcome day 6 and 30
myocardial glucose- and Free Fatty Acid-extraction
cardiac output
Regional left ventricle function

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby Sygehus, Department of Cardiology

🇩🇰

Aarhus, Denmark

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