Skip to main content
OpenTrials
Completed

NCT Number: NCT01372397

Reversal of Obesity Cardiomyopathy

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • be interviewed,
  • their clinical charts reviewed, by the research study coordinator and/or the PI, and
  • 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).

Treatment and study plan

Primary outcomes

  1. Cardiac function, myocardial fat deposition

    Time frame: the time frame of the study

Secondary outcomes

  1. liver fat metabolism, plasma lipidomics

    Time frame: the time frame of the study

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Reversal of Obesity Cardiomyopathy After Gastric Bypass

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2011
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.