Cleveland Heart and Metabolic Prevention Study (CHAMPS)
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|ClinicalTrials.gov Identifier: NCT03012022|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : June 2, 2020
|Condition or disease|
|Heart Failure Risk Factors in Healthy Individuals|
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.
|Study Type :||Observational|
|Actual Enrollment :||1208 participants|
|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|
- 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.
- Determination of sub-clinical myocardial dysfunction by echocardiogram [ Time Frame: 10 years ]
- Correlation between functional capacity, as measured by DASI questionnaire, and markers of metabolic and nitrative stress [ Time Frame: 10 years ]
- Correlation between functional capacity, as measured by SF36 version 2 questionnaire, and markers of metabolic and nitrative stress [ Time Frame: 10 years ]
- Correlation between functional capacity, as measured by DASI questionnaire, and markers of cardiac dysfunction [ Time Frame: 10 years ]
- 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
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
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||W. H. Wilson Tang, MD||The Cleveland Clinic|