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

This study has been terminated.
(safety concerns regarding use of rosiglitazone)
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00293137
First received: February 16, 2006
Last updated: September 18, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Phase
Chronic Systolic Heart Failure (Dilated Cardiomyopathy)
 Phase 4

Study Type: Observational
Official Title: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: August 2007
Groups/Cohorts
1
Patients enrolled into the trial must have left ventricular ejection fraction of <40% by echocardiogram within 6 months of enrollment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

see inclusion/exclusion

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293137

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Wilson H Tang, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Anne Kanderian, MD, Cleveland CLinic
ClinicalTrials.gov Identifier: NCT00293137     History of Changes
Other Study ID Numbers: NORDIC
Study First Received: February 16, 2006
Last Updated: September 18, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Chronic systolic heart failure
Heart Failure

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
Heart Failure, Systolic
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013