Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure

NCT ID: NCT00804882

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

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.

Conditions

Metabolic Syndrome; Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Mexican Americans with heart failure and metabolic syndrome

No interventions assigned to this group

2

Mexican Americans with heart failure without metabolic syndrome

No interventions assigned to this group

3

Non-Hispanic White Americans with heart failure and metabolic syndrome

No interventions assigned to this group

4

Non-Hispanic White Americans with heart failure without metabolic syndrome

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. age 18-59 years

2. known diagnosis of HF

3. complete 2-dimensional and Doppler echocardiogram within the last 12 months.

Exclusion Criteria

1. history of CAD determined by recorded or self-reported history of CAD and/or revascularization

2. recent history (previous 6 months) of decompensated HF

3. heart transplant

4. diagnosis of diabetes (rationale: diabetes independently predicts HF)

5. race/ethnicity other than Mexican American or non-Hispanic white.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Texas Tech University Health Sciences Center

Principal Investigators

Rey P Vivo, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Countries

United States

Other Identifiers

L08-174

Identifier Type: -

Identifier Source: org_study_id