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Cleveland Heart and Metabolic Prevention Study (CHAMPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012022
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic

Brief Summary:
The purpose of this research study is to investigate the role of chemical reactions, such as inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function properly). The investigators are interested in studying the various chemical pathways for cell damage to determine which are the most prevalent and/or most important. The investigators also want to determine whether waste products of oxidative damage or other chemicals can be monitored in the blood or urine and serve as an indication of the existence and severity of overall heart disease activity. The investigators further want to determine whether certain proteins, called enzymes, affect this cell damage, or whether the presence or absence of certain genes which create different forms of these enzymes correlate with the development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in heart muscle structure) or other cardiovascular diseases.

Condition or disease
Heart Failure Risk Factors in Healthy Individuals

Detailed Description:

This is a single-center study conducted at the Cleveland Clinic. The target population for this study is very broad and goes beyond any specific cohort or community. Participants will be mainly recruited from the greater Cleveland/Akron area, but any volunteer meeting the inclusion/exclusion criteria is eligible for participation.

The overall goal of the Cleveland Heart And Metabolic Prevention Study (CHAMPS) is to determine the role of nitrative stress in the development and progression of heart failure (HF) and left ventricular systolic dysfunction (LVSD). The investigators have previously developed and performed preliminary clinical validation studies on multiple specific molecular footprints of known pathways of nitric oxide (NO) pathobiology that affect substrate availability for NO production or generation of NO-derived oxidants as a result of nitrative stress. For each these molecular markers and indices, mechanistic links to cardiovascular diseases have been demonstrated. However, these processes may be differentially expressed in different proportions at different stages of LVSD/HF disease progression, and certainly may vary among different individuals. It is the investigators' hypothesis that the interplay of many of these processes contribute to development of subclinical myocardial dysfunction (SMD), and the progression to overt LVSD and HF.

In order to help determine the role of nitrative stress in the development and progression of heart failure and left ventricular systolic dysfunction study participants will receive many non-invasive, research only, procedures as well as a blood draw and urine collection. The procedures performed may include electrocardiogram (ECG), echocardiogram, carotid intima-medial thickness measurements, ankle-brachial index, bioelectrical impedance analysis, pulse wave velocity analysis, spirometry, exhaled nitric oxide analysis, and venous occlusion strain-gauge plethysmography. The specific tests performed on each participant will be at the description of the primary investigator and not all participants will receive all tests. All participants will have blood and urine collections and all participants will be asked to fill out questionnaires pertaining to family history, personal medical history and estimates of functional capacity.

Specific aims include:

Aim 1: To test the hypothesis that levels of specific nitric oxide (NO)-mediated processes are associated with the presence of SMD and LVSD/HF.

Aim 2: To test the hypothesis that levels of specific NO-mediated processes are associated with prospective risks for development of adverse cardiovascular events and overt HF in stable patients without LVSD/HF at baseline.

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Study Type : Observational
Actual Enrollment : 1208 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Nitrative Stress in Heart Failure: The Cleveland Heart and Metabolic Prevention Study (CHAMPS)
Study Start Date : November 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Healthy Volunteers



Primary Outcome Measures :
  1. Correlation between metabolic and/or nitrative stress markers and predefined clinical endpoints [ Time Frame: 10 years ]
    Clinical endpoints include acute myocardial infarction, acute coronary syndrome, congestive heart failure, serious cardiac arrhythmia, peripheral vascular disease, cerebrovascular events and death. Events will be aggregated into a common category (e.g. MACE) for statistical analysis and reporting. These aggregated events data will then be correlated with each biomarker of interest.


Secondary Outcome Measures :
  1. Determination of sub-clinical myocardial dysfunction by echocardiogram [ Time Frame: 10 years ]
  2. Correlation between functional capacity, as measured by DASI questionnaire, and markers of metabolic and nitrative stress [ Time Frame: 10 years ]
  3. Correlation between functional capacity, as measured by SF36 version 2 questionnaire, and markers of metabolic and nitrative stress [ Time Frame: 10 years ]
  4. Correlation between functional capacity, as measured by DASI questionnaire, and markers of cardiac dysfunction [ Time Frame: 10 years ]
  5. Correlation between functional capacity, as measured by SF36 version 2 questionnaire, and markers of cardiac dysfunction [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Whole Blood, Serum, Plasma, Red Blood Cells, Buffy Coat, Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers
Criteria

Inclusion Criteria:

  • Either age 40 years or older OR age 18 years or older with a family history of heart failure or cardiac dysfunction (the heart does not function properly).
  • Able and willing to consent to the study protocol, including an overnight (≥10 hour) fast.

Exclusion Criteria:

  • Known history of heart failure or cardiomyopathy (LVSD, defined by left ventricular ejection fraction ≤45%) at the time of enrollment
  • Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment of present study (subject can be considered enrollment after 1 month if deemed clinically stable)
  • Any hospitalization or emergency room visits for any cause <1 month of enrollment present study
  • Known life expectancy <6 months at the time of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012022


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: W. H. Wilson Tang, MD The Cleveland Clinic
Publications:

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Responsible Party: Wilson Tang, Principal Investigator, Staff Cellular and Molecular Medicine and Cardiovascular Medicine, The Cleveland Clinic, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03012022    
Other Study ID Numbers: 10-727
1R01HL103931 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wilson Tang, The Cleveland Clinic:
Healthy Volunteers
Congestive Heart Failure
Cardiomyopathies
Heart Failure
Risk Factors
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases