Sex and Obesity: Effects on Heart Failure Study

Completed

• Conditions: Obesity; Heart Failure
• Interventions: Procedure: PET (Positron Emission Tomography); Procedure: Echocardiogram; Radiation: ^15O-water; Radiation: 1-^11C-palmitate; Radiation: 1-^11C-glucose

• Registration Number: NCT00776035
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02-01
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Primary Completion: 2011-04-02
• Study Completion: 2011-04-02
• Status Verified: 2023-11
• Results First Submitted: 2023-11-09
• Results First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Results First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men with heart failure	1-^11C-palmitate	Men with obesity-related heart failure
Women with heart failure	PET (Positron Emission Tomography)	Women with obesity-related heart failure
Women with heart failure	^15O-water	Women with obesity-related heart failure
Men with heart failure	^15O-water	Men with obesity-related heart failure
Men with heart failure	1-^11C-glucose	Men with obesity-related heart failure
Women with heart failure	1-^11C-palmitate	Women with obesity-related heart failure
Women with heart failure	1-^11C-glucose	Women with obesity-related heart failure
Women with heart failure	Echocardiogram	Women with obesity-related heart failure
Men with heart failure	PET (Positron Emission Tomography)	Men with obesity-related heart failure
Men with heart failure	Echocardiogram	Men with obesity-related heart failure

Primary Outcome Measures

Name	Time	Method
Average Myocardial Blood Flow	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.

Secondary Outcome Measures

Name	Time	Method
Average Myocardial Fatty Acid Utilization	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States