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Reversal of Obesity Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01372397
Recruitment Status : Active, not recruiting
First Posted : June 13, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Cardiomyopathy

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reversal of Obesity Cardiomyopathy After Gastric Bypass
Study Start Date : May 2010
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Cardiac function, myocardial fat deposition [ Time Frame: the time frame of the study ]

Secondary Outcome Measures :
  1. liver fat metabolism, plasma lipidomics [ Time Frame: the time frame of the study ]

Biospecimen Retention:   Samples With DNA
Blood Samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are obese with 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.

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01372397     History of Changes
Other Study ID Numbers: 10-0613
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases