Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Male or female, aged \>18 years

• First diagnosis of idiopathic DCM (defined according to the most recent ESC Guidelines) with LVEF ≤ 40% and clinical indication to diagnostic coronary angiography

• Willing and able to give informed consent for participation in the study

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria di Ferrara
NOT_YET_RECRUITING
Ferrara
Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino
NOT_YET_RECRUITING
Genova
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Ospedale Galeazzi di Sant'Ambrogio IRCCS
NOT_YET_RECRUITING
Milan
University of Naples Federico II
NOT_YET_RECRUITING
Naples
Fondazione Policlinico Universitario A. Gemelli IRCCS
NOT_YET_RECRUITING
Roma
Azienda Ospedaliero-Universitaria Sant'Andrea
NOT_YET_RECRUITING
Rome
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
Azienda Ospedaliera Universitaria di Verona
RECRUITING
Verona
Contact Information
Primary
Natascia Antonioli
studi.clinici.cardiologia@aovr.veneto.it
0039 0458122320
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2030-01-31
Participants
Target number of participants: 190
Treatments
Experimental: Microvascular assessment
Coronary microvascular assessment
Sponsors
Leads: Azienda Ospedaliera Universitaria Integrata Verona
Collaborators: Abbott Medical Devices

This content was sourced from clinicaltrials.gov