Metabolic Modulation as Treatment in Acute Heart Failure | NCT00449423

Studies
Metabolic Modulation as Treatment in Acute Heart Failure

NCT00449423

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

Oct 25, 2007Estimated

Enrollment

32Estimated

Phase

Phase 2

Conditions

Acute Heart Failure

Interventions

acipimox

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to slow recruitment

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2007

Last Update Posted Date

Oct 25, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Name	Type	Description	Arm Group Labels	Other Names
acipimox	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac index
pulmonary Wedge Pressure
Ejection fraction

Secondary Outcomes

Measure	Description	Time Frame
myocardial glucose- and Free Fatty Acid-extraction
cardiac output
Regional left ventricle function

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mads Halbirk, dr.	Aarhus University Hospital, Department of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby Sygehus, Department of Cardiology		Aarhus	Aarhus	8200	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
C027696	acipimox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided