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Estrogen Diastolic Heart Failure

Primary Purpose

Menopause

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estradiol/Norethindrone acetate
Placebo
Sponsored by
Gretchen Wells
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menopause

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hormone replacement therapy

Placebo

Arm Description

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

Inert ingredients by mouth oral daily for 12 weeks

Outcomes

Primary Outcome Measures

Diastolic Function Assessed by Echocardiography
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks

Secondary Outcome Measures

Activity Level Assessed by Duke Activity Status Index (DASI)
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.
Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)
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.
B-type Natriuretic Peptide (BNP) Levels
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.

Full Information

First Posted
February 23, 2016
Last Updated
July 11, 2018
Sponsor
Gretchen Wells
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1. Study Identification

Unique Protocol Identification Number
NCT02693002
Brief Title
Estrogen Diastolic Heart Failure
Official Title
Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment goals not being met
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gretchen Wells

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hormone replacement therapy
Arm Type
Active Comparator
Arm Description
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inert ingredients by mouth oral daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Estradiol/Norethindrone acetate
Other Intervention Name(s)
Activella
Intervention Description
Estradiol/Norethindrone acetate 1mg/0.5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
inactive ingredient
Primary Outcome Measure Information:
Title
Diastolic Function Assessed by Echocardiography
Description
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Activity Level Assessed by Duke Activity Status Index (DASI)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)
Description
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.
Time Frame
Baseline and 12 weeks
Title
B-type Natriuretic Peptide (BNP) Levels
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen L Wells, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be provided to participants of the study.

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Estrogen Diastolic Heart Failure

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