NCT00664222

Brief Summary

The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

April 18, 2008

Last Update Submit

April 21, 2008

Conditions

Chronic Stable Heart Failure

Keywords

heart failureinsulin resistanceinflammatory cytokinespironolactonefurosemide

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    16 weeks

Interventions

spironolactone + furosemideDRUG

spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic stable heart failure

You may not qualify if:

  • renal dysfunction or under treatment with antidiabetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureInsulin Resistance

Interventions

SpironolactoneFurosemide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSulfanilamidesSulfonamidesAmidesAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

January 1, 2004

Study Completion

December 1, 2005

Last Updated

April 22, 2008

Record last verified: 2008-04