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OpenTrials
Completed

NCT Number: NCT00776035

Sex and Obesity: Effects on Heart Failure Study

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Heart Diseases Heart Failure Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET (positron emission tomography)

Procedure

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

Echocardiogram

Procedure

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

^15O-water

Radiation

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.

1-^11C-palmitate

Radiation

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.

1-^11C-glucose

Radiation

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..

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Official study title

Sex and Obesity Effects on Myocardial Blood Flow and Metabolism

Important dates

Study start
2000
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2008
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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