Reversal of Obesity Cardiomyopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Linda Peterson, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01372397
First received: June 10, 2011
Last updated: February 20, 2014
Last verified: February 2014
  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:

Primary Outcome Measures:
  • Cardiac function, myocardial fat deposition [ Time Frame: the time frame of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver fat metabolism, plasma lipidomics [ Time Frame: the time frame of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Samples


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  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 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
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: February 20, 2014
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 April 17, 2014