NCT00449423

Brief Summary

The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

March 19, 2007

Last Update Submit

October 24, 2007

Conditions

Acute Heart Failure

Keywords

Acute heart failureMetabolic modulation

Outcome Measures

Primary Outcomes (3)

  • Cardiac index

  • pulmonary Wedge Pressure

  • Ejection fraction

Secondary Outcomes (4)

  • myocardial glucose- and Free Fatty Acid-extraction

  • cardiac output

  • Regional left ventricle function

  • outcome day 6 and 30

Interventions

acipimoxDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute heart failure
  • NYHA class III - IV.
  • ejection fraction \<35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby Sygehus, Department of Cardiology

Aarhus, Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

acipimox

Study Officials

  • Mads Halbirk, dr.

    Aarhus University Hospital, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

March 1, 2007

Study Completion

October 1, 2007

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

DK(1)