Sex and Obesity: Effects on Heart Failure Study

November 9, 2023 updated by: Washington University School of Medicine

Sex and Obesity Effects on Myocardial Blood Flow and Metabolism

Sex has a major impact on myocardial metabolism and blood flow. In those 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 those 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 used radioactive materials and a PET (positron emission Tomography) scan to study the blood flow and substrate metabolism of the heart.

Hypotheses: 1) Women with heart failure with reduced ejection fraction (HFrEF) will have higher levels of heart blood flow and fatty acid metabolism and lower glucose metabolism rates than men with HFrEF. A secondary Aim was to test the hypothesis that body mass index (BMI), a measure of obesity, correlated with myocardial blood flow and myocardial metabolism measures in patients with HFrEF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with heart failure were recruited for this study from the Washington University in St. Louis VO2 peak database, which consisted of participants who had been referred to and completed VO2 testing in the Cardiac Rehabilitation-run laboratory since 1998.

Description

Inclusion criteria

  • Heart failure (HF) and a systolic ejection fraction <45% per a recent echocardiogram report)
  • Nonischemic HF New York Heart Association Class II-III
  • Ambulatory
  • Able to give informed consent
  • On a stable medical regimen including the standard-of-care HF medications (i.e., a beta-blocker, ACE-inhibitor or angiotensin receptor blocker [ARB])

Exclusion criteria

  • Participants who were pregnant or lactating
  • Actively losing weight
  • Nonsedentary (performing aerobic exercise > 30 minutes x 3 times/week)
  • Those who have more than Class I hypertension
  • Those who require alterations in beta-blocker or ACE or ARB-inhibition medication
  • Those with hypertrophic, constrictive, or restrictive cardiomyopathies
  • Those unable to lie flat in the PET scanner
  • Severe major organ system dysfunction (other than heart failure)
  • Significant coronary artery disease by catheterization
  • Those unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men with heart failure
Men with obesity-related heart failure
Procedure: PET (Positron Emission Tomography)
This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm.
Other Names:
  • PET scan
Procedure: Echocardiogram
An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan.
Other Names:
  • Echo
Radiation: ^15O-water
This is a radioactive tracer used to study blood flow in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
Radiation: 1-^11C-palmitate
This is a radioactive tracer used to study fatty acid usage in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
Radiation: 1-^11C-glucose
This is a radioactive tracer used to study glucose usage in the heart during the PET scan. It was administered intravenously at a dose of 20 Mci..
Women with heart failure
Women with obesity-related heart failure
Procedure: PET (Positron Emission Tomography)
This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm.
Other Names:
  • PET scan
Procedure: Echocardiogram
An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan.
Other Names:
  • Echo
Radiation: ^15O-water
This is a radioactive tracer used to study blood flow in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
Radiation: 1-^11C-palmitate
This is a radioactive tracer used to study fatty acid usage in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
Radiation: 1-^11C-glucose
This is a radioactive tracer used to study glucose usage in the heart during the PET scan. It was administered intravenously at a dose of 20 Mci..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Myocardial Blood Flow
Time Frame: Study Day 2
Myocardial blood flow (MBF) was measured using ^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Study Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Myocardial Fatty Acid Utilization
Time Frame: Study Day 2
Myocardial fatty acid (FA) utilization was measured using 1-^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Study Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

Investigators

  • Principal Investigator: Linda Peterson, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2000

Primary Completion (Actual)

April 2, 2011

Study Completion (Actual)

April 2, 2011

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimated)

October 20, 2008

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-1128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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