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

Primary Purpose

Chronic Systolic Heart Failure (Dilated Cardiomyopathy)

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Chronic Systolic Heart Failure (Dilated Cardiomyopathy) focused on measuring Chronic systolic heart failure, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients enrolled into the trial must meet all of the following criteria: 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 Mild-to-moderate signs and/or symptoms of heart failure (NYHA functional Class I-II) 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: Known or confirmed newly-diagnosed diabetes mellitus (2004 ADA criteria) Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment Hospitalization or emergency room visits for heart failure exacerbation, or use of inotropic agents < 1 month NYHA class III or IV Current treatment with thiazolidinediones Allergy to rosiglitazone, or liver insufficiency (ALT > 2.5x upper limits of normal) Heart failure due to congenital heart disease, primary valvular disease, hypertrophic cardiomyopathy, or heart failure caused by known cardiotoxic agents (e.g. adriamycin) End-stage renal failure on renal replacement therapy (dialysis) Life expectancy, or expected cardiac transplantation within 12 months of enrollment 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 Unable or unwilling to consent to all components of the protocol. Patients unwilling to undergo 6-month follow-up should not be enrolled.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Arm Label

1

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2006
Last Updated
September 18, 2008
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00293137
Brief Title
NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
Acronym
NORDIC
Official Title
Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy
Study Type
Observational

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
safety concerns regarding use of rosiglitazone
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure (Dilated Cardiomyopathy)
Keywords
Chronic systolic heart failure, Heart Failure

7. Study Design

Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Description
Patients enrolled into the trial must have left ventricular ejection fraction of <40% by echocardiogram within 6 months of enrollment
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients enrolled into the trial must meet all of the following criteria: 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 Mild-to-moderate signs and/or symptoms of heart failure (NYHA functional Class I-II) 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: Known or confirmed newly-diagnosed diabetes mellitus (2004 ADA criteria) Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment Hospitalization or emergency room visits for heart failure exacerbation, or use of inotropic agents < 1 month NYHA class III or IV Current treatment with thiazolidinediones Allergy to rosiglitazone, or liver insufficiency (ALT > 2.5x upper limits of normal) Heart failure due to congenital heart disease, primary valvular disease, hypertrophic cardiomyopathy, or heart failure caused by known cardiotoxic agents (e.g. adriamycin) End-stage renal failure on renal replacement therapy (dialysis) Life expectancy, or expected cardiac transplantation within 12 months of enrollment 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 Unable or unwilling to consent to all components of the protocol. Patients unwilling to undergo 6-month follow-up should not be enrolled.
Study Population Description
see inclusion/exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson H Tang, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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