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Estrogen Diastolic Heart Failure

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ClinicalTrials.gov Identifier: NCT02693002
Recruitment Status : Terminated (Enrollment goals not being met)
First Posted : February 26, 2016
Results First Posted : July 11, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gretchen Wells, University of Kentucky

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 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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693002


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

Responsible Party: Gretchen Wells, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02693002     History of Changes
Other Study ID Numbers: 15-0798-F6A
First Posted: February 26, 2016    Key Record Dates
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:
Estrogens
Heart Failure
Heart Diseases
Cardiovascular Diseases
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral