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NCT05062057 · ClinicalTrials.gov registry record
Menopause Racing Heart Study
A clinical trial, sponsored by Indiana University.
- Completed
- Registry status
- 30
- Enrollment target
NCT05062057 is a clinical trial that has completed, run by Indiana University. The registered enrollment target is 30 participants.
The verdict
NCT05062057 has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
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 EC
Interventions
- DEVICE Adhesive ambulatory ECG recording patches
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-01-06 |
| Est. Completion | 2024-02-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05062057
The ClinicalTrials.gov registry entry for NCT05062057 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Adhesive ambulatory ECG recording patches is the first listed.
NCT05062057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05062057 about?
NCT05062057 is a clinical study titled "Menopause Racing Heart Study". 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) abno...
What is the current status of trial NCT05062057?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2022-01-06. Estimated completion is 2024-02-16.
What interventions are being tested in trial NCT05062057?
The interventions under investigation include: Adhesive ambulatory ECG recording patches (DEVICE).
Who is sponsoring clinical trial NCT05062057?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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