Reversal of Obesity Cardiomyopathy

ID: NCT01372397
Status: Active, not recruiting
Phase: N/A
Start Date: May 01, 2010
First Submitted: June 10, 2011
Last Updated: February 06, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Cardiomyopathy
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cardiomyopathy

N/A

Tracking Information

First Submitted DateJune 10, 2011
Last Update Posted DateFebruary 06, 2018
Start DateMay 01, 2010
Anticipated Completion DateFebruary 01, 2019
Primary Completion DateFebruary 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Cardiac function, myocardial fat deposition [Time Frame: the time frame of the study]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • liver fat metabolism, plasma lipidomics [Time Frame: the time frame of the study]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleReversal of Obesity Cardiomyopathy
Official TitleReversal of Obesity Cardiomyopathy After Gastric Bypass
Brief Summary

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

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
50
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Cardiomyopathy
Target Follow-Up Duration N/A
Biospecimen:
Retention: Samples With DNA
Description: Blood Samples
Sampling MethodProbability Sample
Study PopulationPatients who are obese with heart failure and will undergo gastric bypass surgery or who have already had gastric bypass surgery.
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment50
Completion DateFebruary 01, 2019
Eligibility 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).
GenderAll
Age35 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01372397
Other Study ID Numbers
10-0613
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Linda R Peterson, MD
Washington University School of Medicine