Sex and Obesity: Effects on Heart Failure Study

NCT00776035 | Completed Results

• 1 other identifier: 07-1128
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Heart Failure

Keywords

Obesity; Heart; Failure; PET (positron emission tomography); radiation; metabolism

Outcome Measures

Primary Outcomes (1)

• Average Myocardial Blood Flow

  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 Outcomes (1)

• Average Myocardial Fatty Acid Utilization

  Study Day 2

Study Arms (2)

Men with heart failure

Men with obesity-related heart failure

Procedure: PET (Positron Emission Tomography); Procedure: Echocardiogram; Radiation: ^15O-water; Radiation: 1-^11C-palmitate; Radiation: 1-^11C-glucose

Women with heart failure

Women with obesity-related heart failure

Procedure: PET (Positron Emission Tomography); Procedure: Echocardiogram; Radiation: ^15O-water; Radiation: 1-^11C-palmitate; Radiation: 1-^11C-glucose

Interventions

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.

Also known as: PET scan

Men with heart failure; Women with heart failure

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.

Also known as: Echo

Men with heart failure; Women with heart failure

^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.

Men with heart failure; Women with heart failure

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.

Men with heart failure; Women with heart failure

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..

Men with heart failure; Women with heart failure

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Males and females assigned so at birth are eligible to participate. Since the purpose was to evaluate sex-related differences in blood flow and metabolism without the effects of exogenous hormones, those taking the latter were excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 \[ARB\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

• Essop MF, Opie LH. Metabolic therapy for heart failure. Eur Heart J. 2004 Oct;25(20):1765-8. doi: 10.1016/j.ehj.2004.08.019. No abstract available.

  PMID: 15474689 BACKGROUND

• Taegtmeyer H, Salazar R. Myocardial metabolism: a new target for the treatment of heart disease? Curr Hypertens Rep. 2004 Dec;6(6):414-5. doi: 10.1007/s11906-004-0033-5. No abstract available.

  PMID: 15527683 BACKGROUND

• Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. doi: 10.1152/physrev.00006.2004.

  PMID: 15987803 BACKGROUND

• Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure. N Engl J Med. 2002 Aug 1;347(5):305-13. doi: 10.1056/NEJMoa020245.

  PMID: 12151467 BACKGROUND

• Peterson LR, Herrero P, Schechtman KB, Racette SB, Waggoner AD, Kisrieva-Ware Z, Dence C, Klein S, Marsala J, Meyer T, Gropler RJ. Effect of obesity and insulin resistance on myocardial substrate metabolism and efficiency in young women. Circulation. 2004 May 11;109(18):2191-6. doi: 10.1161/01.CIR.0000127959.28627.F8. Epub 2004 May 3.

  PMID: 15123530 BACKGROUND

• Kates AM, Herrero P, Dence C, Soto P, Srinivasan M, Delano DG, Ehsani A, Gropler RJ. Impact of aging on substrate metabolism by the human heart. J Am Coll Cardiol. 2003 Jan 15;41(2):293-9. doi: 10.1016/s0735-1097(02)02714-6.

  PMID: 12535825 BACKGROUND

• Peterson LR, Soto PF, Herrero P, Schechtman KB, Dence C, Gropler RJ. Sex differences in myocardial oxygen and glucose metabolism. J Nucl Cardiol. 2007 Jul;14(4):573-81. doi: 10.1016/j.nuclcard.2007.03.001. Epub 2007 Jun 27.

  PMID: 17679067 BACKGROUND

• Davila-Roman VG, Vedala G, Herrero P, de las Fuentes L, Rogers JG, Kelly DP, Gropler RJ. Altered myocardial fatty acid and glucose metabolism in idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2002 Jul 17;40(2):271-7. doi: 10.1016/s0735-1097(02)01967-8.

  PMID: 12106931 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Non diagnostic genetic samples

MeSH Terms

Conditions

Obesity; Heart Failure

Interventions

Magnetic Resonance Spectroscopy; Caves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Results Point of Contact

• Title: Linda R. Peterson, MD, Professor of Medicine and Radiology
• Organization: Washington University School of Medicine

lpeterso@wustl.edu

314-362-4577

Study Officials

• Linda Peterson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: February 1, 2000
• Primary Completion: April 2, 2011
• Study Completion: April 2, 2011
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2023-11

Locations

US (1)