NCT06500988 Mobile Health Technology-Enabled AFib Management
| NCT ID | NCT06500988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 248 participants in total. It began in 2025-06-03 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 or older at time of consent 2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation 3. BMI (Body Mass Index) ≥ 27.0 Exclusion Criteria: 1. Permanent Afib (decision has been made not to attempt sinus rhythm) 2. Severe valvular disease 3. Moderate mitral valve stenosis 4. Prior cardiac surgery 5. Presence of implanted cardiac device 6. History of cardiac arrest 7. Left ventricular ejection fraction (LVEF) ≤ 35% 8. Life expectancy \< 1 year 9. Non-English speaking 10. Treating clinician deems unsafe for exercise 11. Any other reason that makes patient unsuitable for study at the discretion of the PI
Contact & Investigator
Nino Isakadze, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06500988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500988 currently recruiting?
Yes, NCT06500988 is actively recruiting participants. Contact the research team at nisakad1@jhmi.edu for enrollment information.
Where is the NCT06500988 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States.
Who is sponsoring the NCT06500988 clinical trial?
NCT06500988 is sponsored by Johns Hopkins University. The principal investigator is Nino Isakadze, MD at Johns Hopkins University. The trial plans to enroll 248 participants.
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