Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: losartan
  • losartan 50-100mg for 16 weeks

Primary Measures

• insulin resistance
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Secondary Measures

• inflammatory cytokines
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• chronic stable heart failure

Exclusion Criteria:

• renal dysfunction or under treatment with antidiabetic agents

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tottori University Hospital

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663377

Study ID Number: #656

ClinicalTrials.gov Identifier: NCT00663377

Health Authority: Japan: Ministry of Health, Labor and Welfare