Effects of Losartan on Insulin Resistance in Patients With Heart Failure

Tracking Information
First Submitted Date ICMJE	April 18, 2008
First Posted Date ICMJE	April 22, 2008
Last Update Posted Date	April 22, 2008
Study Start Date ICMJE	April 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: April 18, 2008)	insulin resistance [ Time Frame: 16 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: April 18, 2008)	inflammatory cytokines [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Losartan on Insulin Resistance in Patients With Heart Failure
Official Title ICMJE	Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors
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.
Detailed 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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Heart Failure
Intervention ICMJE	Drug: losartan; losartan 50-100mg for 16 weeks
Study Arms	Not Provided
Publications *	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 β-blockers. Circ J. 2010 Nov;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.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: April 18, 2008)	16
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: chronic stable heart failure Exclusion Criteria: renal dysfunction or under treatment with antidiabetic agents
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00663377
Other Study ID Numbers ICMJE	#656
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kazuhide Ogino, Center for Clinical Residency Program, Tottori University Hospital
Study Sponsor ICMJE	Tottori University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Tottori University Hospital
Verification Date	April 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP