Estrogen Diastolic Heart Failure

July 11, 2018 updated by: Gretchen Wells

Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hormone replacement therapy
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Drug: Estradiol/Norethindrone acetate
Estradiol/Norethindrone acetate 1mg/0.5 mg
Other Names:
  • Activella
Placebo Comparator: Placebo
Inert ingredients by mouth oral daily for 12 weeks
Drug: Placebo
inactive ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic Function Assessed by Echocardiography
Time Frame: Baseline and 12 weeks
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Level Assessed by Duke Activity Status Index (DASI)
Time Frame: Baseline and 12 weeks
Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks.
Baseline and 12 weeks
Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)
Time Frame: Baseline and 12 weeks
Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time.
Baseline and 12 weeks
B-type Natriuretic Peptide (BNP) Levels
Time Frame: Baseline and 12 weeks
Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gretchen Wells

Investigators

  • Principal Investigator: Gretchen L Wells, MD, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0798-F6A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be provided to participants of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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