ArrhythmiaRHYME-HDNCT07491237
RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases
An observational study of Arrhythmia and Cardiomyopathy, Dilated, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Cardiomyopathy, Dilated, Systolic Dysfunction
- What is being tested?
- speckle tracking echocardiography
- How many people
- 253 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jun 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are candidates for electrophysiological and/or electrostimulation procedures
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francesca Augusta Gabrielli, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Francesca Augusta Gabrielli, MD PhD, 00390630155288, francescaaugusta.gabrielli@policlinicogemelli.it
About this study
Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence.
In recent decades, with advances in medical knowledge and technology, non-pharmacological therapies for arrhythmias have become increasingly popular. These fall into two broad categories: therapies aimed at electrostimulation and those aimed at ablation of arrhythmias.
Read more
The selection of patients eligible for these procedures is essential for the effectiveness of the therapy, the reduction of complications and the optimisation of resources.
Not all patients, even those selected according to guidelines, respond equally to the chosen therapy. Other patients, due to their clinical/ECG characteristics, do not have clear indications and remain in a borderline area where the class of evidence and/or recommendation of the guidelines is less stringent. Still others develop recurrences or complications during follow-up that require further intervention.
In this context, it is essential in the study of these patients not only to use standard instrumental examinations, such as echocardiograms, Holter ECGs and stress tests (simple and cardiopulmonary), but also and above all to use advanced imaging methods (STE, 3D echo, MRI, CT, PET-CT) and remote monitoring tools that integrate diagnostic algorithms managed by artificial intelligence.
In light of these considerations, our project consists of conducting an observational study that includes all patients with arrhythmias who are candidates for electrostimulation and/or ablation procedures at the Arrhythmology Unit and/or followed up at the Arrhythmology Clinic of our Polyclinic, in order to assess the clinical and/or imaging characteristics associated with a worse prognosis in this population, in terms of response to therapy and development of complications. Our main aim is to identify, within the above-mentioned population, the subgroups of responder patients versus non-responder patients, i.e. those with a worse prognosis , who deserve greater attention and more frequent follow-up.
- Conditions
- Arrhythmia, Cardiomyopathy, Dilated, Systolic Dysfunction, Atrial Fibrillation, Ventricular Arrythmia, Heart Failure
- Being tested
- speckle tracking echocardiography
- Medical subject headings
- Arrhythmias, Cardiac, Cardiomyopathy, Dilated, Atrial Fibrillation, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking echocardiographyDiagnostic test
clinical and echocardiographic evaluation during hospitalization and at 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of pathophysiological mechanisms
analysis of pathophysiological mechanisms underlying the relationship between the electrical and mechanical components of myocardial cells and to identify possible prognostic markers useful in optimising the therapeutic process for patients.
Measured: 6 months
relationship between arrhythmias and cardiac function
relationship between arrhythmias and cardiac function evaluated with speckle tracking echocardiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Jun 2026
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Augusta Gabrielli, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491237
- Sponsor's protocol ID
- 27021
- Acronym
- RHYME-HD
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases
- ClinicalTrials.gov ID
- NCT07491237
- Acronym / sponsor ID
- RHYME-HD / 27021
- Conditions
- Arrhythmia, Cardiomyopathy, Dilated, Systolic Dysfunction, Atrial Fibrillation, Ventricular Arrythmia, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence.
In recent decades, with advances in medical knowledge and technology, non-pharmacological therapies for arrhythmias have become increasingly popular. These fall into two broad categories: therapies aimed at electrostimulation and those aimed at ablation of arrhythmias.
The selection of patients eligible for these procedures is essential for the effectiveness of the therapy, the reduction of complications and the optimisation of resources.
Not all patients, even those selected according to guidelines, respond equally to the chosen therapy. Other patients, due to their clinical/ECG characteristics, do not have clear indications and remain in a borderline area where the class of evidence and/or recommendation of the guidelines is less stringent. Still others develop recurrences or complications during follow-up that require further intervention.
In this context, it is essential in the study of these patients not only to use standard instrumental examinations, such as echocardiograms, Holter ECGs and stress tests (simple and cardiopulmonary), but also and above all to use advanced imaging methods (STE, 3D echo, MRI, CT, PET-CT) and remote monitoring tools that integrate diagnostic algorithms managed by artificial intelligence.
In light of these considerations, our project consists of conducting an observational study that includes all patients with arrhythmias who are candidates for electrostimulation and/or ablation procedures at the Arrhythmology Unit and/or followed up at the Arrhythmology Clinic of our Polyclinic, in order to assess the clinical and/or imaging characteristics associated with a worse prognosis in this population, in terms of response to therapy and development of complications. Our main aim is to identify, within the above-mentioned population, the subgroups of responder patients versus non-responder patients, i.e. those with a worse prognosis , who deserve greater attention and more frequent follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are candidates for electrophysiological and/or electrostimulation procedures
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speckle tracking echocardiographyclinical and echocardiographic evaluation during hospitalization and at 6 months | Diagnostic test | – |
Primary outcome
analysis of pathophysiological mechanisms
Time frame: 6 months
analysis of pathophysiological mechanisms underlying the relationship between the electrical and mechanical components of myocardial cells and to identify possible prognostic markers useful in optimising the therapeutic process for patients.
relationship between arrhythmias and cardiac function
Time frame: 6 months
relationship between arrhythmias and cardiac function evaluated with speckle tracking echocardiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Augusta Gabrielli, MD contact
Francesca Augusta Gabrielli, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Cardiomyopathy, Dilated, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Augusta Gabrielli, MD (+390630154187, francescaaugusta.gabrielli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of pathophysiological mechanisms (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.