NCT00549614

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 7, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

October 25, 2007

Last Update Submit

October 6, 2009

Conditions

Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (3)

  • left ventricular ejection Fraction

    4 weeks

  • exercise capacity

    4 weeks

  • muscular metabolism

    4 weeks

Secondary Outcomes (3)

  • regional left ventricular function

    4 weeks

  • insulin resistance

    4 weeks

  • full body metabolism

    4 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: acipimox

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

acipimoxDRUG

capsule, 250 mg, 4 times daily for 28 days

1
placeboDRUG

capsule, 250 mg, 4 times daily for 28 days

2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aarhus Universityhospital, Skejby

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Interventions

acipimox

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mads Halbirk

    B-research, Aarhus Universityhospital, skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 26, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

October 7, 2009

Record last verified: 2009-10

Locations

DK(1)