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

This study has been terminated.
(Principal investigator is leaving the institution to obtain further training.)
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00804882
First received: December 8, 2008
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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.


Condition
Metabolic Syndrome
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-Ischemic Heart Failure (CHAMP-HF)

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood will be collected


Enrollment: 0
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mexican Americans and Non-Hispanic White Americans with heart failure

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804882

Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Rey P Vivo, MD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Rey Vivo, MD, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00804882     History of Changes
Other Study ID Numbers: L08-174
Study First Received: December 8, 2008
Last Updated: May 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Metabolic syndrome
Heart failure
Mexican Americans
Ethnic differences
Echocardiography

Additional relevant MeSH terms:
Heart Failure
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014