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Effects of Losartan on Insulin Resistance in Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Tottori University Hospital
ClinicalTrials.gov Identifier:
NCT00663377
First received: April 18, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 18, 2008
April 18, 2008
April 2006
Not Provided
insulin resistance [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
inflammatory cytokines [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Losartan on Insulin Resistance in Patients With Heart Failure
Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors

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.

Chronic heart failure (CHF) is associated with marked insulin resistance, characterized by both fasting and stimulated hyperinsulinemia. Furthermore, insulin resistance is a predictor of CHF and associated with more severe disease and a worse prognosis in patients with CHF. In CHF patients, therefore, insulin resistance is not merely a function of adiposity and may have implications in the pathophysiology of CHF disease progression. Angiotensin II negatively modulates insulin-mediated actions by regulating multiple levels of the insulin signaling cascade such as the insulin receptor, IRS, and PI3-kinase. Furthermore, both ACE inhibitors and angiotensin II receptor blockers (ARB) improve glycemic status not only in patients with type II diabetes but also in patients with hypertension and the metabolic syndrome. On the other hand, it is well known that some cytokines, such as TNF-α, are involved with pathophysiology of insulin resistance and CHF. However, it is still unclear whether the ARB improves insulin resistance in CHF patients already treated with ACE inhibitors and whether there is the relationship between insulin resistance and inflammatory cytokines in CHF patients already treated with ACE inhibitors. Therefore, 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heart Failure
Drug: losartan
losartan 50-100mg for 16 weeks
Not Provided
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 ?-blockers. Circ J. 2010 Oct 25;74(11):2346-52. Epub 2010 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2007
Not Provided

Inclusion Criteria:

  • chronic stable heart failure

Exclusion Criteria:

  • renal dysfunction or under treatment with antidiabetic agents
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00663377
#656
No
Kazuhide Ogino, Center for Clinical Residency Program, Tottori University Hospital
Tottori University Hospital
Not Provided
Not Provided
Tottori University Hospital
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP