NCT07486986

Brief Summary

EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2032

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

March 23, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

MenopauseT2DMSleep Disruption

Outcome Measures

Primary Outcomes (6)

  • Reduced septal e' velocity

    Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.

    Baseline to 4 years.

  • Increased E/e' ratio

    Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.

    Baseline to 4 years.

  • Increased tricuspid regurgitation (TR) velocity

    Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.

    Baseline to 4 years.

  • Change in pulmonary artery systolic pressure (PASP)

    Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.

    Baseline to 4 years.

  • Change in E/A ratio

    Decrease of E/A ratio below 1 indicates diastolic dysfunction, and an increase of E/A ratio over 2 indicates advance failure. Measured by echocardiography.

    Baseline to 4 years.

  • Change in left atrial size

    Left Atrial Enlargement (LAE) is abnormal stretching or widening of the upper left heart chamber, typically caused by chronic pressure or volume overload. Measured by echocardiography.

    Baseline to 4 years.

Secondary Outcomes (2)

  • Decline in left ventricular global longitudinal strain (GLS)

    Baseline to 4 years.

  • Decline in left atrial strain

    Baseline to 4 years.

Study Arms (1)

Evaluation

This is a non-randomized study following individuals in perimenopause with type 2 diabetes. The population will follow a 4 evaluation/observation period with associated questionnaires and medical exams, including bloodwork and cardiac echo.

Other: 4 years of clinical evaluations.

Interventions

4 years of clinical evaluations.OTHER

The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.

Evaluation

Eligibility Criteria

Age48 Years - 58 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will be selected from patients at the University of Ottawa Heart Institute, The Ottawa Hospital, and from within the Ottawa and surrounding area community.

You may qualify if:

  • Female Sex
  • Age range 48-58 years
  • In menopausal transition phase (pre-menopause or peri-menopause)
  • Diagnosis of Type 2 Diabetes Mellitus
  • Have access to and regularly use a smartphone with internet access

You may not qualify if:

  • Male Sex
  • Currently Pregnant
  • Prior history of total hysterectomy or bilateral oophorectomy
  • Prior diagnosis of any of the following:
  • Coronary Vascular Disease (CVD) including coronary heart disease, heart failure, congenital heart disease stroke/transient ischemic attack, valvular heart disease, peripheral vascular disease, aortapathy, atrial fibrillation or flutter, other CVD.
  • \- Untreated serious mental illness (e.g, untreated psychosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kerri Anne Mullen, Ph.D.

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Van Dam

CONTACT

613-696-7000CVandam@ottawaheart.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

March 23, 2026

Record last verified: 2026-01