N/A N=37 Randomized Double-blind Treatment

Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

Myocardial Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT00600106 ↗

Enrolled (actual)

Serious AEs

5.4%

Results posted

Dec 2017

Primary outcome: Primary: Inducible Myocardial Ischemia — -13.8; -7.0 percent changed in PCR/ATP ratio — p=0.36

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 1/10 NA/EE (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Cedars-Sinai Medical Center
Primary completion: May 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Inducible Myocardial Ischemia	-7.7; 1.1	0.17
PRIMARY Endothelial Dysfunction (FMD)	8.8; 7.3	0.38
PRIMARY Endothelial Dysfunction (FMD)	8.8; 7.3	0.38
PRIMARY Inducible Myocardial Ischemia	-7.7; 1.1	0.17
SECONDARY Physical Functional Disability - Functional Capacity (METs)	6.1; 5.4	0.49
SECONDARY Quality of Life - Menopause Symptoms	41; 89; 59; 78; 35; 67	—
SECONDARY Quality of Life - Menopause Symptoms	41; 89; 59; 78; 35; 67	—
SECONDARY Quality of Life - Health Survey	59.4; 44.4; 58.8; 25.0; 76.5; 66.7	—
SECONDARY Quality of Life - Health Survey	59.4; 44.4; 58.8; 25.0; 76.5; 66.7	—
SECONDARY Physical Functional Disability - Functional Capacity (METs)	6.1; 5.4	0.49
SECONDARY Physical Functional Disability - Functional Capacity (Metabolism Equivalents)	6.1; 5.4	0.40
SECONDARY Physical Functional Disability - Functional Capacity (Metabolism Equivalents)	6.1; 5.4	0.40
SECONDARY Physical Functional Disability - Functional Capacity (Exercise Induced ST Segment Depression)	-0.79; -0.79	0.99
SECONDARY Physical Functional Disability - Functional Capacity (Stress Induced ST Segment Depression)	-1.05; -0.63	0.21

Summary

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.

Eligibility Criteria

Inclusion Criteria

Postmenopausal WISE and nonWISE study participants
Normal/minimally diseased coronary arteries ( 15% from control) performed at a WISE or nonWISE site
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
Reversible stress radionuclide perfusion defect > equivocal and not attributable to breast/imaging artifact. performed as part of the WISE protocol
Coronary artery flow reserve 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.

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Data sourced from ClinicalTrials.gov (NCT00600106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.