NCT00663377

Brief Summary

The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

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 heart-failure

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 heart-failure

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

April 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.1 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 18, 2008

Conditions

Heart Failure

Keywords

Heart FailureInsulin ResistanceLosartanACE inhibitorInflammatory cytokine

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    16 weeks

Secondary Outcomes (1)

  • inflammatory cytokines

    16 weeks

Interventions

losartanDRUG

losartan 50-100mg for 16 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
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

Related Publications (1)

  • Ogino K, Kato M, Furuse Y, Kinugasa Y, Kaetsu Y, Mizuta E, Sugihara S, Ishida K, Yanagihara K, Hisatome I, Shigemasa C. Addition of losartan to angiotensin-converting enzyme inhibitors improves insulin resistance in patients with chronic heart failure treated without beta-blockers. Circ J. 2010 Nov;74(11):2346-52. doi: 10.1253/circj.cj-10-0395. Epub 2010 Sep 4.

    PMID: 20827028DERIVED

MeSH Terms

Conditions

Heart FailureInsulin Resistance

Interventions

Losartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

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

April 1, 2006

Study Completion

March 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04