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NCT00293137 Clinical Trial

NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy

Chronic Systolic Heart Failure (Dilated Cardiomyopathy) Clinical Trial

— NORDIC  

Official title:
Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00293137
Other study ID # NORDIC
Secondary ID
Status Terminated
Phase Phase 4
First received February 16, 2006
Last updated September 18, 2008
Start date February 2006
Est. completion date August 2007

Study information
Verified date September 2008
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The principal aim is to investigate the safety and efficacy of rosiglitazone in patients with chronic systolic heart (Dilated cardiomyopathy). We hypothesize that in patients with heart failure, rosiglitazone is safe, and can reduce nitric oxide (NO) derived oxidative stress (in particular, nitrotyrosine) thereby improving endothelial dysfunction, left ventricular performance, and metabolic parameters.

Description:

The study will be a single center, double-blind, prospective placebo controlled trial of 60 non-diabetic heart failure patients. Prior to administration of study medication, a medical history, physician exam, blood draw, laser Doppler imaging (Periscan system), venous occlusion strain gauge plethysmography, metabolic exercise stress test and 2D and 3D echocardiograms will be performed. Patients will then be randomized to receive rosiglitazone 2mg/day oral versus placebo with up-titration to 4mg/day oral versus placebo at 3 months. Each study arm will have 30 patients who will participate for 6 months. Follow up assessments will be completed at 6 weeks, 3 months and 6 months post randomization.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients enrolled into the trial must meet all of the following criteria:

1. Chronic, stable, euvolemic, heart failure optimally treated for at least 3 months with stable doses of ACE inhibitors or angiotensin-receptor blockers and beta-blockers

2. Mild-to-moderate signs and/or symptoms of heart failure (NYHA functional Class I-II)

3. Left ventricular ejection fraction of <40% by echocardiogram within 6 months of randomization or enrollment

Exclusion Criteria:

Patients meeting one or more of the following criteria are not eligible for randomization into the trial:

1. Known or confirmed newly-diagnosed diabetes mellitus (2004 ADA criteria)

2. Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment

3. Hospitalization or emergency room visits for heart failure exacerbation, or use of inotropic agents < 1 month

4. NYHA class III or IV

5. Current treatment with thiazolidinediones

6. Allergy to rosiglitazone, or liver insufficiency (ALT > 2.5x upper limits of normal)

7. Heart failure due to congenital heart disease, primary valvular disease, hypertrophic cardiomyopathy, or heart failure caused by known cardiotoxic agents (e.g. adriamycin)

8. End-stage renal failure on renal replacement therapy (dialysis)

9. Life expectancy, or expected cardiac transplantation within 12 months of enrollment

10. Women who are pregnant, or who are planning on becoming pregnant or are lactating. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization and must use contraceptive agents

11. Unable or unwilling to consent to all components of the protocol. Patients unwilling to undergo 6-month follow-up should not be enrolled.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Endpoint • Comparison of NO-derived oxidants, systemic ADMA, skin blood flow, forearm blood flow and exhaled NO. • Correlation of NO-derived oxidants, systemic ADMA, skin blood flow, forearm blood flow and exhaled NO to functional capacity 120 minutes No