Atrial Fibrillation Clinical Trials

Find Atrial Fibrillation Clinical Trials Near You

Home Monitoring for the Detection of Subclinical Atrial Fibrillation in Hypertensive Patients at Moderate to High Risk of Developing Arrhythmia. BP/AF MODE Study.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Objective: to determine the usefulness of home blood pressure and heart rhythm monitoring strategy in the detection of subclinical atrial fibrillation.

Methods: observational, cohort, prospective, multicenter study involving 25 researchers from six Latin American countries. Home blood pressure monitoring and single-lead electrocardiogram recording were performed in a population at moderate to high risk of developing atrial fibrillation. A minimum of twenty 30-second electrocardiographic and blood pressure recordings over 7 days using an Omron Complete Hem-7530 T ECG device will be uploaded from a mobile phone app and then sent to a database for analysis.

Conclusions: the results of this study can provide a simple and accessible home monitoring system for detecting subclinical atrial fibrillation and for optimizing the predictive capacity of arrhythmia risk scores through deep learning.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 1\. Hypertensive patients of both sexes over 75 years of age. 2. Hypertensive patients between 65 and 75 years of age are associated with one of the following risk factors:

‣ Obesity

⁃ Type 2 diabetes

⁃ Obstructive sleep apnea syndrome

⁃ Electrocardiogram showing left ventricular hypertrophy.

⁃ Left ventricular hypertrophy on echocardiogram.

⁃ Left atrial dilation.

⁃ Coronary artery disease

⁃ Chronic kidney disease

⁃ Heart failure with ejection fraction \> 50%

‣ Alcohol intake

‣ Frequent supraventricular ectopic beats

Locations
Other Locations
Argentina
British Sanatorium Cardiovascular Research Center
RECRUITING
Rosario
Contact Information
Primary
Daniel L Piskorz, MD
daniel.l.piskorz@gmail.com
5493415416828
Backup
Ricardo López Santi, MD
lopezsan@live.com.ar
54 92215081467
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 499
Treatments
Hypertensive patients older 75 or Hypertensive patients between 65 and 75 at moderate-high risk AF
The 30-second home ECG tracings will be obtained using the Omron Complete Hem-7530 T ECG device (Omron Healthcare Co., Ltd., Japan). The connection and smartphone app download will be available from Omron Connect free of charge on the Google Play Store: https://play.google.com/store/apps/details?id=jp.co.omron.healthcare.omron\_connect\&hl=es\_419\&pli=1 and on the iOS App Store: https://apps.apple.com/mx/app/omron-connect/id1003177043. Two duplicate ECG recordings will be required daily: the first in the morning before breakfast and taking the prescribed medication, and another in the evening before dinner and taking the afternoon/evening medication. Additional ECG recordings will be required if the patient experiences any symptoms.
Related Therapeutic Areas
Sponsors
Leads: Cardiovascular Research Center Rosario British Sanatorium

This content was sourced from clinicaltrials.gov