Estrogen Diastolic Heart Failure

NCT02693002 | Terminated Phase 4 Results DMC

• 1 other identifier: 15-0798-F6A
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Diastolic Function Assessed by Echocardiography

  Change in diastolic function as assessed by echocardiography from baseline to 12 weeks

  Baseline and 12 weeks

Secondary Outcomes (3)

• Activity Level Assessed by Duke Activity Status Index (DASI)

  Baseline and 12 weeks

• Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)

  Baseline and 12 weeks

• B-type Natriuretic Peptide (BNP) Levels

  Baseline and 12 weeks

Study Arms (2)

Hormone replacement therapy

ACTIVE COMPARATOR

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

Drug: Estradiol/Norethindrone acetate

Placebo

PLACEBO COMPARATOR

Inert ingredients by mouth oral daily for 12 weeks

Drug: Placebo

Interventions

Estradiol/Norethindrone acetate DRUG

Estradiol/Norethindrone acetate 1mg/0.5 mg

Also known as: Activella

Hormone replacement therapy

Placebo DRUG

inactive ingredient

Placebo

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gretchen Wells: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

estradiol, norethindrone drug combination

Limitations and Caveats

Due to limited enrollment, there were too few participants to draw statistically meaningful conclusions from collected data.

Results Point of Contact

• Title: Dr. Gretchen Wells, PI
• Organization: University of Kentucky

gretchen.wells@uky.edu

Study Officials

• Gretchen L Wells, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 8, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)