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Sex and Obesity: Effects on Heart Failure Study

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: NCT00776035
Recruitment Status : Active, not recruiting
First Posted : October 20, 2008
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:

Sex has a major impact on myocardial metabolism and blood flow. In subjects without heart failure men's hearts tend to use proportionally more glucose and women's hearts use more fat and have higher blood flow.

Obesity is a major risk factor for Heart Failure. In subjects without heart failure, increasing body mass index is predictive of increased blood flow and fatty acid metabolism in women, but not men.

To measure blood flow and metabolism we will be using radioactive materials and a PET (positron emission Tomography)scan to study the metabolism of the heart.

Hypotheses: 1) Women with nonischemic heart failure will have higher levels of heart blood flow and fatty acid metabolism and lower glucose metabolism rates than men with nonischemic heart failure 2) Patients with obesity-related HF have a myocardial metabolic profile that is similar to that of obese subjects without heart failure and different (higher FA metabolism) from that of nonobese Heart failure patients.


Condition or disease Intervention/treatment
Obesity Heart Failure Procedure: PET (positron Emission Tomography) Procedure: Echocardiogram Procedure: VO2 peak test Procedure: Body composition Study Radiation: 15O water Radiation: 11C Acetate Radiation: 11C Palmitate Radiation: 11C Glucose

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Sex and Obesity Effects on Myocardial Blood Flow and Metabolism
Study Start Date : January 2008
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
heart failure
Obesity related Heart failure population
 Procedure: PET (positron Emission Tomography)
this is a diagnostic scan that requires the injection of radioactive tracers into an IV placed in the arm.
Other Name: PET scan

Procedure: Echocardiogram
an ultrasound of the heart
Other Name: Echo

Procedure: VO2 peak test
walking on a treadmill during which you will breath in and out through a tube

Procedure: Body composition Study
a scan of your entire body measuring Body Mass Index, fat percentage etc...
Other Name: DEXA scan

Radiation: 15O water
radioactive tracer used to study blood flow during the PET scan

Radiation: 11C Acetate
radioactive tracer that helps study heart metabolism

Radiation: 11C Palmitate
radioactive tracer used to study fatty acid usage in the heart

Radiation: 11C Glucose
radioactive tracer usde to study glucose usage in the heart


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial blood flow, glucose metabolism, oxygen metabolism, and fat metabolism [ Time Frame: the time frame of the study ]
    The heart uses sugars, fats, oxygen to make its energy for function.


Biospecimen Retention:   Samples With DNA
Non diagnostic genetic samples

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
obesity related heart failure patients
Criteria

Inclusion Criteria: men and women

  • Non Ischemic Heart failure, ejection fraction <40%, premenopausal, Obese(BMI >30),Lean, age 20-50, non diabetic

Exclusion Criteria:

  • Pregnancy, lactating, actively losing weight, nonsedentary, greater than Class I hypertension,require alterations in heart medications, Diabetics.
Contacts and Locations
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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): NCT00776035


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
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Principal Investigator: Linda Peterson, MD Washington University School of Medicine
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00776035    
Other Study ID Numbers: 07-1128
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Keywords provided by Washington University School of Medicine:
Obesity
Heart
Failure
 PET
radiation
metabolism
Additional relevant MeSH terms:
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Heart Failure
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Heart Diseases
Cardiovascular Diseases