Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism

NCT00565916 | Terminated Results

• 5 other identifiers: 489K23HL077179IRB# 04-0812RDRC# 538FGCRC# 966
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Estrogen and progesterone are two main female sex hormones. When a woman goes through menopause, the body's production of estrogen and progesterone significantly decreases. Recent studies have shown that the breakdown of fatty acids in cardiac muscle is important in maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women. This study will determine in postmenopausal women whether estrogen increases the heart's ability to use fats as energy and whether progesterone decreases this effect.

Conditions

Postmenopausal Syndrome

Keywords

Post-Menopausal; PET; Estrogen; Progesterone; Heart Metabolism; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Had an Increase in Myocardial Fatty Acid Utilization.

  Measurements of myocardial fatty acid utilization and oxidation with C\[11\]-Palmitate and PET in healthy postmenopausal women who take either estrogen alone or with progesterone. The primary outcome measure was designed to determine prospectively whether estrogen will increase the heart's fatty acid utilization and whether progestins will attenuate this effect, in a manner similar to what was seen in an observational study of hormone replacement therapy (HRT) in post-menopausal women. To this end, we had anticipated enrolling 30 healthy post-menopausal women for assessment of cardiac fatty acid metabolism using positron emission tomography (PET) and radioactive C\[11\]-Palmitate both before and after 3 days of hormone replacement therapy. These volunteers were to be randomized to receive either estrogen alone (E) or combined estrogen/progesterone (EP).

  3 days

Study Arms (2)

estrogen plus progesterone

EXPERIMENTAL

Hormone replacement therapy (HRT): estrogen plus progesterone

Drug: Estrogen; Drug: Progesterone

estrogen plus placebo

ACTIVE COMPARATOR

Hormone replacement therapy (HRT): estrogen plus placebo

Drug: Estrogen; Drug: Placebo

Interventions

Estrogen DRUG

Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo. Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO).

Also known as: Estradiol

estrogen plus placebo; estrogen plus progesterone

Progesterone DRUG

Estrogen plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.

Also known as: prometrium

estrogen plus progesterone

Placebo DRUG

Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.

Also known as: Inactive Drug

estrogen plus placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal woman
• Body mass index less than 30
• Practices normal eating habits
• Stops hormone replacement therapy at least 6 months prior to study entry

You may not qualify if:

• Currently taking hormone replacement therapy
• History of cardiovascular disease
• Family history of coronary artery disease
• Recent history of smoking, high blood pressure, or hyperlipidemia

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63366, United States

Location

Related Publications (5)

• Castelli WP. Cardiovascular disease in women. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 2):1553-60, 1566-7. doi: 10.1016/0002-9378(88)90189-5.

  PMID: 3377033 BACKGROUND

• Bokhari S, Bergmann SR. The effect of estrogen compared to estrogen plus progesterone on the exercise electrocardiogram. J Am Coll Cardiol. 2002 Sep 18;40(6):1092-6. doi: 10.1016/s0735-1097(02)02111-3.

  PMID: 12354433 BACKGROUND

• Babiker FA, De Windt LJ, van Eickels M, Grohe C, Meyer R, Doevendans PA. Estrogenic hormone action in the heart: regulatory network and function. Cardiovasc Res. 2002 Feb 15;53(3):709-19. doi: 10.1016/s0008-6363(01)00526-0.

  PMID: 11861041 BACKGROUND

• Petrie MC, Dawson NF, Murdoch DR, Davie AP, McMurray JJ. Failure of women's hearts. Circulation. 1999 May 4;99(17):2334-41. doi: 10.1161/01.cir.99.17.2334. No abstract available.

  PMID: 10226101 BACKGROUND

• McKee PA, Castelli WP, McNamara PM, Kannel WB. The natural history of congestive heart failure: the Framingham study. N Engl J Med. 1971 Dec 23;285(26):1441-6. doi: 10.1056/NEJM197112232852601. No abstract available.

  PMID: 5122894 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Estrogens; Estradiol; Progesterone

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Results Point of Contact

• Title: Dr. Robert Gropler MD
• Organization: Washington University School of Medicine

groplerr@mir.wustl.edu

314-747-3878

Study Officials

• Pablo Soto, MD

  Washington University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: August 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Locations

US (1)