Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

NCT00600106 | Completed Results DMC

• 2 other identifiers: 9260IRB#0505140
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (4)

• Inducible Myocardial Ischemia

  Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.

  Baseline

• Endothelial Dysfunction (FMD)

  Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of endothelial dysfunction. Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\].

  Baseline

• Endothelial Dysfunction (FMD)

  Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of vasomotor function. Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\].

  12 weeks

• Inducible Myocardial Ischemia

  Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.

  12 weeks

Secondary Outcomes (10)

• Physical Functional Disability - Functional Capacity (METs)

  Baseline

• Quality of Life - Menopause Symptoms

  Baseline

• Quality of Life - Menopause Symptoms

  12 weeks

• Quality of Life - Health Survey

  Baseline

• Quality of Life - Health Survey

  12 weeks

Study Arms (2)

Hormone replacement therapy

ACTIVE COMPARATOR

Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)

Drug: 1/10 NA/EE

Placebo

PLACEBO COMPARATOR

1mg placebo

Drug: Placebo

Interventions

1/10 NA/EE DRUG

Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)

Hormone replacement therapy

Placebo DRUG

1 mg placebo

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Abnormal P-31 magnetic resonance spectroscopy (a fall in quantitative PCr/ATP ratio \>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 \<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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Parke-Davis: collaborator
• University of Pittsburgh: collaborator
• University of Florida: collaborator
• Allegheny University: collaborator
• University of Alabama at Birmingham: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Cedars-Sinai Women's Heart Center, 8631 W. 3rd St, Suite 740

Los Angeles, California, 90048, United States

Location

Related Publications (45)

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  PMID: 12117397 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.

  PMID: 20569710 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: C. Noel Bairey Merz
• Organization: Cedars-Sinai Medical Center

Noel.BaireyMerz@cshs.org

310-423-9680

Study Officials

• C. Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

• Carl Pepine, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Steve Reis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Nathaniel Reichek, MD

  Allegheny University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• William Rogers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Vijay Misra, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Robert B Weiss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Sheryl Kelsey, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• George Sopko, MD

  National Institute of Health (WISE Project Officer)

  STUDY DIRECTOR

• James Symons, PhD

  Parke-Davis

  STUDY DIRECTOR

• Connie McLaughlin, PharmD

  Parke-Davis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: December 1, 1999
• Primary Completion: May 1, 2003
• Study Completion: March 1, 2010
• Last Updated: April 24, 2019
• Results First Posted: December 19, 2017

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)