Effect of 4 Weeks Treatment With Acipimox in Patients Wit... | NCT00549614

Studies
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure

NCT00549614

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 7, 2009Estimated

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

acipimox
placebo

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 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2008Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 25, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 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 6, 2009

Last Update Posted Date

Oct 7, 2009Estimated

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 left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: acipimox
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acipimox	Drug	capsule, 250 mg, 4 times daily for 28 days	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left ventricular ejection Fraction		4 weeks
exercise capacity		4 weeks
muscular metabolism		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
regional left ventricular function		4 weeks
insulin resistance		4 weeks
full body metabolism

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

EF<40 %
IHD
NYHA-class II-III.

Exclusion Criteria:

pregnancy
severe renal failure
new brady- or tachyArrhythmia
Severe stenotic valvular disease
myocardial infarction within last 6 weeks
insulin treated diabetes mellitus
peptic ulcer
pregnancy or lactating women
allergy towards tested medicine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 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	B-research, Aarhus Universityhospital, skejby	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Aarhus Universityhospital, Skejby		Aarhus N		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C027696	acipimox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided