Estrogen Diastolic Heart Failure

• ClinicalTrials.gov Identifier: NCT02693002
• Recruitment Status: Terminated
• First Posted: February 26, 2016
• Results First Posted: July 11, 2018
• Last Update Posted: August 8, 2018
• Sponsor: Gretchen Wells
• Information provided by (Responsible Party): Gretchen Wells, University of Kentucky

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).

Condition or disease	Intervention/treatment	Phase
Menopause	Drug: Estradiol/Norethindrone acetate; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy
• Study Start Date: February 2016
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

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 Name: Activella
Placebo Comparator: Placebo; Inert ingredients by mouth oral daily for 12 weeks	Drug: Placebo; inactive ingredient

Outcome Measures

Primary Outcome Measures :

1. Diastolic Function Assessed by Echocardiography [ Time Frame: Baseline and 12 weeks ]
   Change in diastolic function as assessed by echocardiography from baseline to 12 weeks

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

Gretchen Wells

Investigators

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

More Information

• Responsible Party: Gretchen Wells, Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02693002
• Other Study ID Numbers: 15-0798-F6A
• First Posted: February 26, 2016
• Results First Posted: July 11, 2018
• Last Update Posted: August 8, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

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

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases; Norethindrone; Norethindrone Acetate; Estradiol; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptives, Oral, Synthetic