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Hispanics With Metabolic Syndrome and Non-Ischemic Heart Failure (CHAMP-HF)
This study is currently recruiting participants.
Verified by Texas Tech University Health Sciences Center, December 2008
Sponsors and Collaborators: Texas Tech University Health Sciences Center
HRSA/Maternal and Child Health Bureau
Information provided by: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00804882
  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

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Cross-Sectional
Official Title: Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-Ischemic Heart Failure (CHAMP-HF)

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

Biospecimen Description:

Blood will be collected


Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804882

Contacts
Contact: Rey P Vivo, MD 806-743-3155 ext 242 rey.vivo@ttuhsc.edu
Contact: Selim R Krim, MD 806-743-3155 ext 284 selim.krim@ttuhsc.edu

Locations
United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Beth Taraban, MA     806-743-4566     beth.taraban@ttuhsc.edu    
Contact: Cathy Lovett     806-743-4433     cathy.lovett@ttuhsc.edu    
Principal Investigator: Rey P Vivo, MD            
Sponsors and Collaborators
Texas Tech University Health Sciences Center
HRSA/Maternal and Child Health Bureau
Investigators
Principal Investigator: Rey P Vivo, MD Texas Tech University Health Sciences Center
  More Information

Responsible Party: Texas Tech University Health Sciences Center ( Rey Vivo, MD )
Study ID Numbers: L08-174
Study First Received: December 8, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00804882  
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

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009