Reversal of Obesity Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

Reversal of Obesity Cardiomyopathy After Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372397
• Other study ID #: 10-0613
• Status: Completed
• Start date: May 2010
• Est. completion date: April 26, 2012

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 26, 2012
• Est. primary completion date: April 26, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function, myocardial fat deposition		the time frame of the study
Secondary	liver fat metabolism, plasma lipidomics		the time frame of the study