Subclinical Atrial Fibrillation Home Monitoring in Hypertensive Patients
Recruiting · NCT07058831 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cardiovascular Research Center Rosario British Sanatorium
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Atrial fibrillation is a highly prevalent and incidental arrhythmia, often asymptomatic, and frequently detected incidentally or in association with a stroke. Subclinical atrial fibrillation increases cardioembolic risk, highlighting the need for timely diagnosis. New wireless devices capable of recording heart rhythm, combined with innovative artificial intelligence tools, could be useful in the prediction and detection of this arrhythmia. 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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 1\. History of any type of atrial fibrillation. 2. Receiving pharmacological treatments with potential impact on heart rhythm. 3. History of potentially malignant ventricular arrhythmias. 4. Uncontrolled hypothyroidism or hyperthyroidism. 5. Significant chronic obstructive pulmonary disease.
Where it is running
2 locations listed.
- British Sanatorium Cardiovascular Research Center - Rosario, Santa Fe Province, Argentina
- British Sanatorium Cardiovascular Research Center - Rosario, Santa Fe Province, Argentina