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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

Tracking Information
First Submitted Date October 17, 2008
First Posted Date October 20, 2008
Last Update Posted Date March 23, 2020
Study Start Date January 2008
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2014)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sex and Obesity: Effects on Heart Failure Study
Official Title Sex and Obesity Effects on Myocardial Blood Flow and Metabolism
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Non diagnostic genetic samples
Sampling Method Non-Probability Sample
Study Population obesity related heart failure patients
Condition
  • Obesity
  • Heart Failure
Intervention
  • 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
Study Groups/Cohorts heart failure
Obesity related Heart failure population
Interventions:
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 17, 2008)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00776035
Other Study ID Numbers 07-1128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Barnes-Jewish Hospital
Investigators
Principal Investigator: Linda Peterson, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2020