Clinical trial NCT00804882: Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure
Official title: Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-ischemic Heart Failure (CHAMP-HF)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metabolic Syndrome
Heart Failure
Keywords: Metabolic syndrome
Heart failure
Mexican Americans
Ethnic differences
Echocardiography
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2008-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican Americans and Non-Hispanic White Americans with heart failure

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Within 1 week of enrollment
Secondary outcomes:
measure: 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
timeFrame: Within one week of enrollment
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Rey P Vivo, MD
role: PRINCIPAL_INVESTIGATOR
References: