Cleveland Heart and Metabolic Prevention Study (NCT03012022) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cleveland Heart and Metabolic Prevention Study
United States1,208 participantsStarted 2010-11-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between metabolic and/or nitrative stress markers and predefined clinical endpoints