Sex and Obesity: Effects on Heart Failure Study

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00776035
• Collaborator: The Foundation for Barnes-Jewish Hospital (Other)
• Enrollment: 10
• Location: 1
• Duration (Months): 181
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Heart Failure	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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Sex and Obesity Effects on Myocardial Blood Flow and Metabolism
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

heart failure Obesity related Heart failure population

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 Names: PET scan ; Procedure: Echocardiogram; an ultrasound of the heart; Other Names: 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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Myocardial blood flow, glucose metabolism, oxygen metabolism, and fat metabolism [the time frame of the study]

   The heart uses sugars, fats, oxygen to make its energy for function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dávila-Román 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.
• Essop MF, Opie LH. Metabolic therapy for heart failure. Eur Heart J. 2004 Oct;25(20):1765-8.
• 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.
• 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.
• 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. Epub 2004 May 3.
• 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. Epub 2007 Jun 27.
• Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. Review.
• Taegtmeyer H, Salazar R. Myocardial metabolism: a new target for the treatment of heart disease? Curr Hypertens Rep. 2004 Dec;6(6):414-5.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00776035
• Other Study ID Numbers: 07-1128
• First Posted: Oct 20, 2008
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Washington University School of Medicine: Obesity; Heart; Failure; PET; radiation; metabolism
• Additional relevant MeSH terms: Heart Failure; Obesity

Study Results

No Results Posted as of Apr 27, 2022