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Reversal of Obesity Cardiomyopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01372397
First received: June 10, 2011
Last updated: March 29, 2017
Last verified: March 2017
June 10, 2011
March 29, 2017
May 2010
February 2019   (Final data collection date for primary outcome measure)
Cardiac function, myocardial fat deposition [ Time Frame: the time frame of the study ]
Not Provided
Complete list of historical versions of study NCT01372397 on ClinicalTrials.gov Archive Site
liver fat metabolism, plasma lipidomics [ Time Frame: the time frame of the study ]
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Reversal of Obesity Cardiomyopathy
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood Samples
Probability Sample
Patients who are obese with heart failure and will undergo gastric bypass surgery or who have already had gastric bypass surgery.
Cardiomyopathy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
February 2019
February 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01372397
10-0613
Yes
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Linda R Peterson, MD Washington University School of Medicine
Washington University School of Medicine
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP