NCT05062057

Menopause Racing Heart Study

Completed Last updated 14 February 2025

What this trial tests

trial testing Adhesive ambulatory ECG recording patches in Menopause Related Conditions in 30 participants. Completed in 16 February 2024.

Timeline

6 January 2022

Primary endpoint
16 February 2024

16 February 2024

Quick facts

Lead sponsor	Indiana University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	6 January 2022
Primary completion	16 February 2024
Estimated completion	16 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Adhesive ambulatory ECG recording patches

Conditions studied

• Menopause Related Conditions — all drugs for Menopause Related Conditions →

Sponsor

Indiana University

Who can join

Adults 40 to 62, female only, with Menopause Related Conditions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Palpitations occur in more than 25% of women as they approach menopause and after menopause. However, the etiology of menopausal palpitations has not been studied, and it is unknown whether palpitations in menopausal women are caused by underlying arrhythmias or other electrocardiographic (ECG) abnormalities.

Objective:

1\. The primary objective of this exploratory pilot study is to assess whether arrhythmias and/or other ECG abnormalities underlie symptomatic palpitations in peri- and postmenopausal women 2 The secondary objective is to better understand women's palpitations symptom experiences (describe the symptom, its dimensions (frequency, severity, distress, duration, temporal pattern, aggravating/alleviating factors), and any attempted or actual healthcare utilization related to the symptom (provider contacts, discussions, referrals; laboratory or other tests).

In this study, 30 peri- and post-menopausal women will be enrolled to determine if they have underlying arrhythmias or other ECG abnormalities. n=15 peri/postmenopausal women who describe palpitations within the previous 2 weeks and a control group of n=15 peri/postmenopausal women who have not experienced palpitations within 6 months will be enrolled. All participants will undergo placement of a 14-day adhesive ECG monitoring patch \[(Carnation Ambulatory Monitoring (CAM) patch, Bardy Diagnostics\] on their chest. After wearing the patch for 14 days, the patch will be removed, and a 2nd 14-day patch will be placed, for a total of 28 days of ECG recording. Data from the adhesive ECG patches will be uploaded and an assessment of arrhythmias and other ECG changes will be made. In addition, all participants will undergo a semi-structured interview to obtain information on their palpitations symptoms experience.

Changes in study procedure:

1. To reduce participant and staff burden and costs, in April 2023, we reduced the ECG wear time to 14 days and eliminated study visit 3. We did this because the ECH patches did not always adhere well to the skin, necessitating extra study visits, extra patches, and additional costs.
2. Because of the COVID-19 pandemic delays in study initiation and the ECG issues, we recruited 15 rather than the originally planned 20 women in each group. The new sample size was consistent with our limited funding, limited staff resources, and the pilot nature of the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.