Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure

Withdrawn

• Conditions: Heart Failure; Metabolic Syndrome

• Registration Number: NCT00804882
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Within 1 week of enrollment

Secondary Outcome Measures

Name	Time	Method
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	Within one week of enrollment

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States