AzTrials
AzTrials

ObesityNCT00776035

Sex and Obesity: Effects on Heart Failure Study

An observational study of Obesity and Heart Failure, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Obesity, Heart Failure
What is being tested?
PET (Positron Emission Tomography), Echocardiogram and ^15O-water
How many people
19 participants
Where
1 siteUnited States
Study dates
1 Feb 2000to 2 Apr 2011
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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])

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Read more

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.

Being tested
PET (Positron Emission Tomography), Echocardiogram, ^15O-water, 1-^11C-palmitate, 1-^11C-glucose
Keywords
Obesity, Heart, Failure, PET (positron emission tomography), radiation, metabolism
Medical subject headings
Obesity, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET (Positron Emission Tomography)Procedure or surgery

    Also called PET scan

    This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm.

  • EchocardiogramProcedure or surgery

    Also called Echo

    An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan.

  • ^15O-waterRadiation

    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-palmitateRadiation

    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-glucoseRadiation

    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..

Study groups in NCT00776035
Study groupRoleWhat they receive
Men with heart failureMen with obesity-related heart failure
Receives: Procedure: PET (Positron Emission Tomography); Procedure: Echocardiogram; Radiation: ^15O-water; Radiation: 1-^11C-palmitate; Radiation: 1-^11C-glucose
Women with heart failureWomen with obesity-related heart failure
Receives: Procedure: PET (Positron Emission Tomography); Procedure: Echocardiogram; Radiation: ^15O-water; Radiation: 1-^11C-palmitate; Radiation: 1-^11C-glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Study Day 2

Secondary outcomes (1)

  1. Average Myocardial Fatty Acid Utilization

    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.

    Measured: Study Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2008 (estimated)
  2. Study start1 Feb 2000
  3. Primary completion2 Apr 2011
  4. Study completion2 Apr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00776035
Sponsor's protocol ID
07-1128
Status last verified
Nov 2023
First submitted
17 Oct 2008
Last updated
3 May 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 15474689

  • 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.

    PubMed 15527683

  • 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.

    PubMed 15987803

  • 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.

    PubMed 12151467

  • 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.

    PubMed 15123530

  • 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.

    PubMed 12535825

  • 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.

    PubMed 17679067

  • 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.

    PubMed 12106931

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Heart Failure, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Myocardial Blood Flow (time frame: Study Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00776035, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in