Cleveland Heart and Metabolic Prevention Study (CHAMPS)

September 12, 2023 updated by: Wilson Tang, The Cleveland Clinic

Nitrative Stress in Heart Failure: The Cleveland Heart and Metabolic Prevention Study (CHAMPS)

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Volunteers without known cardiomyopathy or heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of sub-clinical myocardial dysfunction by echocardiogram
Time Frame: 10 years
10 years
Correlation between functional capacity, as measured by DASI questionnaire, and markers of cardiac dysfunction
Time Frame: 10 years
10 years
Correlation between functional capacity, as measured by SF36 version 2 questionnaire, and markers of cardiac dysfunction
Time Frame: 10 years
10 years
Correlation between functional capacity, as measured by the Duke Activity Status Index (DASI) questionnaire, and markers of metabolic and nitrative stress
Time Frame: 10 years
10 years
Correlation between functional capacity, as measured by the SF36 version 2 questionnaire, and markers of metabolic and nitrative stress
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: W. H. Wilson Tang, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimated)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-727
  • 1R01HL103931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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