Clinical trial NCT02693002: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Menopause
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 4
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Diastolic Function Assessed by Echocardiography
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Activity Level Assessed by Duke Activity Status Index (DASI)
timeFrame: Baseline and 12 weeks
measure: Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)
timeFrame: Baseline and 12 weeks
measure: B-type Natriuretic Peptide (BNP) Levels
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gretchen L Wells, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: