Metabolic SyndromeCHAMP-HFNCT00804882
Hispanics With Metabolic Syndrome and Non-ischemic Heart Failure
An observational study of Metabolic Syndrome and Heart Failure, run by Texas Tech University Health Sciences Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Metabolic Syndrome, Heart Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Mexican Americans and Non-Hispanic White Americans with heart failure
Who may be able to join
- age 18-59 years
- known diagnosis of HF
- complete 2-dimensional and Doppler echocardiogram within the last 12 months.
Who cannot join
- history of CAD determined by recorded or self-reported history of CAD and/or revascularization
- recent history (previous 6 months) of decompensated HF
- heart transplant
- diagnosis of diabetes (rationale: diabetes independently predicts HF)
- race/ethnicity other than Mexican American or non-Hispanic white.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-ischemic Heart Failure (CHAMP-HF)
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Heart Failure
- Keywords
- Metabolic syndrome, Heart failure, Mexican Americans, Ethnic differences, Echocardiography
- Medical subject headings
- Metabolic Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 week of enrollment
Secondary outcomes (1)
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
Measured: Within one week of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Principal investigator is leaving the institution to obtain further training.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Investigators
- Rey P Vivo, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804882
- Sponsor's protocol ID
- L08-174
- Acronym
- CHAMP-HF
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2008
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation in Hispanics of Accelerated Metabolic Risk Profile and Non-ischemic Heart Failure (CHAMP-HF)
- ClinicalTrials.gov ID
- NCT00804882
- Acronym / sponsor ID
- CHAMP-HF / L08-174
- Conditions
- Metabolic Syndrome, Heart Failure
- Keywords
- Metabolic syndrome, Heart failure, Mexican Americans, Ethnic differences, Echocardiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal investigator is leaving the institution to obtain further training.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mexican Americans and Non-Hispanic White Americans with heart failure
Key inclusion criteria (3 listed)
- age 18-59 years
- known diagnosis of HF
- complete 2-dimensional and Doppler echocardiogram within the last 12 months.
Key exclusion criteria (5 listed)
- history of CAD determined by recorded or self-reported history of CAD and/or revascularization
- recent history (previous 6 months) of decompensated HF
- heart transplant
- diagnosis of diabetes (rationale: diabetes independently predicts HF)
- race/ethnicity other than Mexican American or non-Hispanic white.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rey P Vivo, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Heart Failure, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Within 1 week of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.