Reversal of Obesity Cardiomyopathy



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - 65
Updated:2/9/2018
Start Date:May 2010
End Date:February 2019

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Reversal of Obesity Cardiomyopathy After Gastric Bypass

The overall purpose of this study is to determine if weight loss is beneficial for obese
patients with diastolic heart failure.


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.

To determine if potential subjects meet these criteria, they will:

1. be interviewed,

2. their clinical charts reviewed, by the research study coordinator and/or the PI, and

3. 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).
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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