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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00663377
Other study ID # #656
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2008
Last updated April 18, 2008
Start date April 2006
Est. completion date March 2007

Study information

Verified date April 2008
Source Tottori University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- chronic stable heart failure

Exclusion Criteria:

- renal dysfunction or under treatment with antidiabetic agents

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
losartan
losartan 50-100mg for 16 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tottori University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary insulin resistance 16 weeks
Secondary inflammatory cytokines 16 weeks
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