Menopause Racing Heart Study

Status Recruiting

Clinical Trial 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, 40 peri- and post-menopausal women will be enrolled to determine if they have underlying arrhythmias or other ECG abnormalities. n=20 peri/postmenopausal women who describe palpitations within the previous 2 weeks and a control group of n=20 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Menopause Related Conditions

Clinical Trial Details

NCT number	NCT05062057
Study type	Observational
Source	Indiana University
Contact	James E Tisdale, PharmD
Phone	317-880-5418
Email	jtisdale@purdue.edu
Status	Recruiting
Phase
Start date	January 6, 2022
Completion date	January 31, 2024

View Details

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