Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
NCT ID: NCT00600106
Last Updated: 2019-04-24
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
37 participants
Study Classification
INTERVENTIONAL
Study Start Date
1999-12-31
Study Completion Date
2010-03-31
Brief Summary
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The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.
The main trial duration: December 1999 - May 2003.
The ancillary data analysis project duration: April 2006 - March 2010.
The main trial duration: December 1999 - May 2003.
The ancillary data analysis project duration: April 2006 - March 2010.
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Detailed Description
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See Brief Summary above.
Conditions
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Myocardial Ischemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Hormone replacement therapy
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
Group Type
ACTIVE_COMPARATOR
1/10 NA/EE
Intervention Type
DRUG
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
Placebo
1mg placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
1 mg placebo
Interventions
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1/10 NA/EE
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
Intervention Type
DRUG
Placebo
1 mg placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal WISE and nonWISE study participants
* Normal/minimally diseased coronary arteries (\<50% luminal diameter stenosis in all epicardial coronary arteries) within 36 months of ancillary study entry and no intercurrent MI, PTCA, CABG
* Any one (or multiple) of the following criteria suggestive of myocardial ischemia within 36 months of ancillary study entry:
1. Abnormal P-31 magnetic resonance spectroscopy (a fall in quantitative PCr/ATP ratio \>15% from control) performed at a WISE or nonWISE site
2. Positive exercise stress test (\> or = 1mm horizontal or downsloping, or \> or =1.5mm upsloping ST segment depression measured 0.08 msec after the J point), performed and/or interpretated by a WISE or WISE ancillary ancillary trial investigator
3. Reversible stress radionuclide perfusion defect \> equivocal and not attributable to breast/imaging artifact. performed as part of the WISE protocol
4. Coronary artery flow reserve \<2.25 performed. as part of using the WISE protocol
* No contraindications to 12 weeks of FemHRT or hormone replacement therapy
* Normal mammogram and pelvic exam (including PAP smear for those with an intact uterus) within 12 months of study entry
* Documented normal liver function testing (SGOT) within 3 months of study entry.
* Normal/minimally diseased coronary arteries (\<50% luminal diameter stenosis in all epicardial coronary arteries) within 36 months of ancillary study entry and no intercurrent MI, PTCA, CABG
* Any one (or multiple) of the following criteria suggestive of myocardial ischemia within 36 months of ancillary study entry:
1. Abnormal P-31 magnetic resonance spectroscopy (a fall in quantitative PCr/ATP ratio \>15% from control) performed at a WISE or nonWISE site
2. Positive exercise stress test (\> or = 1mm horizontal or downsloping, or \> or =1.5mm upsloping ST segment depression measured 0.08 msec after the J point), performed and/or interpretated by a WISE or WISE ancillary ancillary trial investigator
3. Reversible stress radionuclide perfusion defect \> equivocal and not attributable to breast/imaging artifact. performed as part of the WISE protocol
4. Coronary artery flow reserve \<2.25 performed. as part of using the WISE protocol
* No contraindications to 12 weeks of FemHRT or hormone replacement therapy
* Normal mammogram and pelvic exam (including PAP smear for those with an intact uterus) within 12 months of study entry
* Documented normal liver function testing (SGOT) within 3 months of study entry.
Exclusion Criteria
* Documented myocardial infarction, coronary artery bypass surgery or mechanical revascularization
* Systolic blood pressure \>200 mmHg or diastolic blood pressure \>105 mmHg
* LDL-cholesterol \>190 mg/dl, triglycerides \> or = 300 mg/dl
* Clinically significant hepatic or renal dysfunction (SGOT more than 1.2 times normal at baseline, serum creatinine \>2)
* Uncontrolled diabetes mellitus (FBS \> or = 225 mg/dl) or new onset diabetes until stabilized
* Clinically significant valvular heart disease, dilated cardiomyopathy, or congestive heart failure (NYHA Class IV or severe Class III)
* Currently on hormone replacement therapy and unwilling/unable to withdraw treatment prior to study, (participants are eligible for study entry 4-8 weeks following hormone replacement therapy withdrawal, at the discretion of the WISE ancillary trial Principal Investigator)
* Previous breast cancer, mammogram suggestive of cancer, or endometrial cancer without hysterectomy
* Abnormal uterine bleeding or abnormal Pap smear (SIL I, II or III, carcinoma in situ, or cancer)
* Previous deep venous thrombosis, pulmonary embolism, or other thromboembolic disorder.
* Alcoholism or drug abuse
* Participation in any other investigational drug or device study
Women with elevated diastolic (\> or = 90 mm Hg) or systolic (\> or = 140 mm Hg) blood pressure, LDL-cholesterol (\> or = 160 mg/dl), fasting blood sugar (\> or = 130 mg/dl) and women who smoke cigarettes will be told their risk factor levels and referred for evaluation and treatment by their private physician.
* Systolic blood pressure \>200 mmHg or diastolic blood pressure \>105 mmHg
* LDL-cholesterol \>190 mg/dl, triglycerides \> or = 300 mg/dl
* Clinically significant hepatic or renal dysfunction (SGOT more than 1.2 times normal at baseline, serum creatinine \>2)
* Uncontrolled diabetes mellitus (FBS \> or = 225 mg/dl) or new onset diabetes until stabilized
* Clinically significant valvular heart disease, dilated cardiomyopathy, or congestive heart failure (NYHA Class IV or severe Class III)
* Currently on hormone replacement therapy and unwilling/unable to withdraw treatment prior to study, (participants are eligible for study entry 4-8 weeks following hormone replacement therapy withdrawal, at the discretion of the WISE ancillary trial Principal Investigator)
* Previous breast cancer, mammogram suggestive of cancer, or endometrial cancer without hysterectomy
* Abnormal uterine bleeding or abnormal Pap smear (SIL I, II or III, carcinoma in situ, or cancer)
* Previous deep venous thrombosis, pulmonary embolism, or other thromboembolic disorder.
* Alcoholism or drug abuse
* Participation in any other investigational drug or device study
Women with elevated diastolic (\> or = 90 mm Hg) or systolic (\> or = 140 mm Hg) blood pressure, LDL-cholesterol (\> or = 160 mg/dl), fasting blood sugar (\> or = 130 mg/dl) and women who smoke cigarettes will be told their risk factor levels and referred for evaluation and treatment by their private physician.
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Parke-Davis
INDUSTRY
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
collaborator
University of Florida
OTHER
Sponsor Role
collaborator
Allegheny University
UNKNOWN
Sponsor Role
collaborator
University of Alabama at Birmingham
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
collaborator
Cedars-Sinai Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Noel Bairey Merz
Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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C. Noel Bairey Merz, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Carl Pepine, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Steve Reis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Nathaniel Reichek, MD
Role: PRINCIPAL_INVESTIGATOR
Allegheny University of the Health Sciences
William Rogers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Vijay Misra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Robert B Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Sheryl Kelsey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
George Sopko, MD
Role: STUDY_DIRECTOR
National Institute of Health (WISE Project Officer)
James Symons, PhD
Role: STUDY_DIRECTOR
Parke-Davis
Connie McLaughlin, PharmD
Role: STUDY_DIRECTOR
Parke-Davis
Locations
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Cedars-Sinai Women's Heart Center, 8631 W. 3rd St, Suite 740
Los Angeles, California, United States
Site Status
Countries
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United States
References
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Johnson BD, Shaw LJ, Pepine CJ, Reis SE, Kelsey SF, Sopko G, Rogers WJ, Mankad S, Sharaf BL, Bittner V, Bairey Merz CN. Persistent chest pain predicts cardiovascular events in women without obstructive coronary artery disease: results from the NIH-NHLBI-sponsored Women's Ischaemia Syndrome Evaluation (WISE) study. Eur Heart J. 2006 Jun;27(12):1408-15. doi: 10.1093/eurheartj/ehl040. Epub 2006 May 23.
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BACKGROUND
von Mering GO, Arant CB, Wessel TR, McGorray SP, Bairey Merz CN, Sharaf BL, Smith KM, Olson MB, Johnson BD, Sopko G, Handberg E, Pepine CJ, Kerensky RA; National Heart, Lung, and Blood Institute. Abnormal coronary vasomotion as a prognostic indicator of cardiovascular events in women: results from the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Feb 17;109(6):722-5. doi: 10.1161/01.CIR.0000115525.92645.16.
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Lanza GA, Colonna G, Pasceri V, Maseri A. Atenolol versus amlodipine versus isosorbide-5-mononitrate on anginal symptoms in syndrome X. Am J Cardiol. 1999 Oct 1;84(7):854-6, A8. doi: 10.1016/s0002-9149(99)00450-6.
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Lerman A, Burnett JC Jr, Higano ST, McKinley LJ, Holmes DR Jr. Long-term L-arginine supplementation improves small-vessel coronary endothelial function in humans. Circulation. 1998 Jun 2;97(21):2123-8. doi: 10.1161/01.cir.97.21.2123.
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Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7. doi: 10.1056/NEJM199405193302003.
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BACKGROUND
Eriksson BE, Tyni-Lenne R, Svedenhag J, Hallin R, Jensen-Urstad K, Jensen-Urstad M, Bergman K, Selven C. Physical training in Syndrome X: physical training counteracts deconditioning and pain in Syndrome X. J Am Coll Cardiol. 2000 Nov 1;36(5):1619-25. doi: 10.1016/s0735-1097(00)00931-1.
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BACKGROUND
Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
Reference Type
RESULT
Merz CN, Olson MB, McClure C, Yang YC, Symons J, Sopko G, Kelsey SF, Handberg E, Johnson BD, Cooper-DeHoff RM, Sharaf B, Rogers WJ, Pepine CJ. A randomized controlled trial of low-dose hormone therapy on myocardial ischemia in postmenopausal women with no obstructive coronary artery disease: results from the National Institutes of Health/National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2010 Jun;159(6):987.e1-7. doi: 10.1016/j.ahj.2010.03.024.
Reference Type
DERIVED
Other Identifiers
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IRB#0505140
Identifier Type: OTHER
Identifier Source: secondary_id
9260
Identifier Type: -
Identifier Source: org_study_id
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Reduction of Triglycerides in Women on Hormone Replacement Therapy
NCT00023543
COMPLETED
PHASE2
Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
NCT00079248
UNKNOWN
NA
Estrogen Replacement and Atherosclerosis (ERA) in Older Women
NCT00000549
COMPLETED
PHASE3
Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
NCT04255160
RECRUITING
PHASE4
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
NCT00224094
COMPLETED
PHASE4