Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure (CHAMP-HF)

April 9, 2015 updated by: Texas Tech University Health Sciences Center

Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-ischemic Heart Failure (CHAMP-HF)

The investigators aim to examine how medical conditions that indicate high cardiometabolic risk, such as increased body weight, high cholesterol levels and high blood pressure, affect heart structure and function among individuals with known HF. Furthermore, this study is being undertaken to identify potential differences in these effects between non-Hispanics whites and Mexican Americans.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

While it is known that Mexican Americans are inordinately affected by metabolic syndrome (MetS), it is unclear how metabolic risk factors impact left ventricular structure and function in Mexican Americans with HF. There is also a gap in the knowledge of the principal etiology of HF in this ethnic group. The overall objective of this pilot study is to define the association between MetS and and non-ischemic HF in Mexican Americans. Our central hypothesis is that there is a positive graded association between an increasing number of metabolic risk factors (ie. individual components of MetS) and increasingly compromised LV structure and function in this population, independent of blood pressure and CAD. Additionally, we hypothesize that this association is more pronounced than that seen in non-Hispanic whites suggesting a predominant role of MetS on HF among Mexican Americans. The rationale that underlies the proposed research is that, once the association between metabolic risk factors and HF in this ethnic group is defined, future research on the impact of management of these metabolic risk factors on HF outcomes, both among Mexican Americans and in the larger population, will be advanced.

Study Type

Observational

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
- Texas
  - Lubbock, Texas, United States, 79430
    - Texas Tech University Health Sciences Center

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 to 59 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mexican Americans and Non-Hispanic White Americans with heart failure

Description

Inclusion Criteria:

age 18-59 years
known diagnosis of HF
complete 2-dimensional and Doppler echocardiogram within the last 12 months.

Exclusion Criteria:

history of CAD determined by recorded or self-reported history of CAD and/or revascularization
recent history (previous 6 months) of decompensated HF
heart transplant
diagnosis of diabetes (rationale: diabetes independently predicts HF)
race/ethnicity other than Mexican American or non-Hispanic white.

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

Observational Models: Case-Only
Time Perspectives: Cross-Sectional

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Mexican Americans with heart failure and metabolic syndrome
2 Mexican Americans with heart failure without metabolic syndrome
3 Non-Hispanic White Americans with heart failure and metabolic syndrome
4 Non-Hispanic White Americans with heart failure without metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate ethnicity-specific differences in the association between increasing number of metabolic risk factors and increasingly compromised LV structure and function among Mexican Americans, in comparison to non-Hispanic whites. Time Frame: Within 1 week of enrollment	Within 1 week of enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the severity of MetS between a cross-sectional sample of Mexican American adults and an age- and gender-matched population of non-Hispanic whites with an established diagnosis of non-ischemic HF Time Frame: Within one week of enrollment	Within one week of enrollment

Collaborators and Investigators

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

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

Principal Investigator: Rey P Vivo, MD, Texas Tech University Health Sciences Center

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

October 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria