Reversal of Obesity Cardiomyopathy
This study is ongoing, but not recruiting participants.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Linda Peterson, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01372397
First received: June 10, 2011
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
The overall purpose of this study is to determine if weight loss is beneficial for obese patients with diastolic heart failure.
| Condition |
|---|
|
Cardiomyopathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Reversal of Obesity Cardiomyopathy After Gastric Bypass |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients who are obese with known diastolic heart failure and will undergo gastric bypass surgery or who have already had gastric bypass surgery.
Criteria
Inclusion Criteria:
- All subjects will have obesity and have a BMI > 35kg/m2.
- Subjects must be between the ages of 35 and 65 years, in order to limit the confounding affect of age on our endpoints.
Subjects must also meet the following definition of diastolic dysfunction:
- have signs/symptoms of heart failure
- have an ejection fraction > 45% based on the rest portion of the screening echocardiography, and
To determine if potential subjects meet these criteria, they will:
- be interviewed,
- their clinical charts reviewed, by the research study coordinator and/or the PI, and
- undergo a history and physical by a physician (Study Day 2). Subjects who are to undergo gastric bypass surgery will be in the intervention arm. They will be matched with control subjects. We will attempt to have no more than one control subject for each gastric surgery subject.
Exclusion Criteria:
- Subjects who have a condition that may masquerade as diastolic heart failure will be excluded (see Research and Design).
- Subjects who are < 35 or > 65 years, > 400lbs (the weight limit of the MRI table) not obese, unstable, not able to lie flat for the imaging studies, not ambulatory, unable to give informed consent, pregnant, lactating, with atrial flutter or fibrillation, current smokers, or who will undergo a different type of bariatric surgery (not Roux-en-Y gastric bypass) will be excluded from participation.
- Those who have evidence of other major systemic diseases (e.g., cancer, significant lung disease, creatinine > 2.0mg/dL, hemoglobin < 10g/dL, and liver function tests twice the normal range) will be excluded.
- Subjects who have > class I hypertension will be excluded. The investigators will exclude patients with an LV ejection fraction < 45% and those with significant pulmonary hypertension (peak artery pressure > 55mmHg).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372397
Locations
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Linda R Peterson, MD | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Linda Peterson, Doctor, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01372397 History of Changes |
| Other Study ID Numbers: | 10-0613 |
| Study First Received: | June 10, 2011 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Cardiomyopathies Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013