RHYthm and Myocardial Function Relationship in Heart Disease
Official title: RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07491237 · Data updated 2026-11-12
This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 253 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | January 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07491237 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a history of arrhythmia requiring non-pharmacological treatment according to guidelines.
✕Probably not a fit
Patients without arrhythmias or without measurable relationships between rhythm and myocardial function may see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses speckle tracking echocardiography to explore the relationship between rhythm disorders and myocardial function in patients with arrhythmias and related heart muscle diseases. It includes both prospective enrollment with informed consent and a retrospective cohort with data protection measures in place. The research aims to identify patterns that may help tailor non-pharmacological therapies such as electrostimulation or ablation by better characterizing who benefits most. No intervention beyond imaging assessments is performed, and data are analyzed to understand associations between rhythm characteristics and heart function. The lead sponsor is a major tertiary care center in Rome, Italy, with no collaborators listed.
Why it matters
Potential benefit: If successful, findings could improve patient selection for non-pharmacological arrhythmia therapies by linking rhythm patterns to heart function.
How similar studies have gone: Previous studies in rhythm and function relationships have shown meaningful insights, but this specific speckle tracking approach in this patient group is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Only patients aged \> 18 years with a history of arrhythmia warranting non-pharmacological treatment according to the guidelines will be selected. * Collection of informed consent for the prospective cohort. * For the retrospective cohort, the Promoter has carried out a Data Protection Impact Assessment (DPIA), which ascertained the adequacy of the technical and organisational measures adopted to ensure the protection of the fundamental rights and freedoms of data subjects, in accordance with Article 89 of Regulation (EU) 2016/679 and the guidelines of the Data Protection Authority. Data processing will be limited to the purposes of the study and conducted in accordance with the principles of minimisation, pseudonymisation and security, in compliance with the guarantees defined by the Data Protection Authority. Exclusion Criteria: * Patients who, upon initial assessment at our centre, do not present arrhythmias that would indicate non-pharmacological treatment. * Patients for whom it is not possible to obtain adequate medical history and/or follow-up through medical examination or telephone consultation. * Refusal to give informed consent to participate in the study.
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Francesca Augusta Gabrielli, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Francesca Augusta Gabrielli, MD
- Email: francescaaugusta.gabrielli@policlinicogemelli.it
- Phone: +390630154187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.