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

September 18, 2008 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

see inclusion/exclusion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
1
Patients enrolled into the trial must have left ventricular ejection fraction of <40% by echocardiogram within 6 months of enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 120 minutes
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Wilson H Tang, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (ESTIMATE)

February 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NORDIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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