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RecruitingNCT07491237RHYME-HDUpdated Sep 10, 2026

RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases

An observational study in Arrhythmia, Cardiomyopathy, Dilated and Systolic Dysfunction, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
253
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Arrhythmia
  • Cardiomyopathy, Dilated
  • Systolic Dysfunction
  • Atrial Fibrillation
  • Ventricular Arrythmia
  • Heart Failure
  • Cardiomyopathies
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who are candidates for electrophysiological and/or electrostimulation procedures

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
253 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testspeckle tracking echocardiography

    clinical and echocardiographic evaluation during hospitalization and at 6 months

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. relationship between arrhythmias and cardiac function

    relationship between arrhythmias and cardiac function evaluated with speckle tracking echocardiography

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07491237
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Jun 23, 2026
Primary completion
Jan 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 10, 2026

Study contacts

Francesca Augusta Gabrielli, MD
Contact
francescaaugusta.gabrielli@policlinicogemelli.it
+390630154187
Francesca Augusta Gabrielli, MD
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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