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Menopause Racing Heart Study

NCT05062057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-02-14

No results posted yet for this study

Summary

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.

Conditions

  • Menopause Related Conditions

Interventions

DEVICE

Adhesive ambulatory ECG recording patches

All women in both groups will undergo sequential placement of two 14-day adhesive ambulatory ECG recording patches for a total of 28 days of ECG recording

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • James E Tisdale, PharmD · Purdue University

Eligibility

Min Age
40 Years
Max Age
62 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2024-02-16
Completion
2024-02-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05062057 on ClinicalTrials.gov