Estrogen Diastolic Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism

NCT00565916

Postmenopausal Syndrome

TERMINATED NA

Estrogen Deficiency on Cardiovascular Risk

NCT06369363

Postmenopausal Symptoms Cardiovascular Diseases

NOT_YET_RECRUITING EARLY_PHASE1

Estrogen, Cytokines and Heart Failure in Women

NCT00041431

Cardiovascular Diseases Heart Failure, Congestive Heart Diseases +1 more

COMPLETED NA

Menopause Effects on Vascular Function

NCT03236545

Cardiovascular Risk Factor

COMPLETED NA

Midlife Cholesterol Study

NCT00361075

Menopause Postmenopause Premenopause +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hormone replacement therapy

Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Estradiol/Norethindrone acetate

Intervention Type DRUG

Estradiol/Norethindrone acetate 1mg/0.5 mg

Placebo

Inert ingredients by mouth oral daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

inactive ingredient

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Estradiol/Norethindrone acetate

Estradiol/Norethindrone acetate 1mg/0.5 mg

Intervention Type DRUG

Placebo

inactive ingredient

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Activella

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.

Exclusion Criteria

* History of hysterectomy, oophorectomy or both
* History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis
* History of bone disease including non-traumatic vertebral fractures on radiography
* Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C \>8, uncontrolled hypertension defined as a systolic blood pressure \>160 mmHg, awaiting organ transplant)
* Previous or current cancer, excluding basal cell carcinoma
* Previous or current thromboembolic disease
* Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)
* Current or previous use of HRT within the past 3 months
* Current or recent (\<12 months) substance abuse, including tobacco use
* No drug interactions with HRT
* No racial or ethnic groups will be excluded

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes