Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure

Heart Failure Clinical Trial

— CHAMP-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00804882
• Other study ID #: L08-174
• Status: Withdrawn
• Phase: N/A
• First received: December 8, 2008
• Last updated: April 9, 2015
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2015
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure
• Metabolic Syndrome
• Metabolic Syndrome X

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No