MedTrace Logo

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

NCT06356727 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Heart Failure
  • Left Ventricular Dysfunction
  • Idiopathic Dilated Cardiomyopathy

Interventions

DIAGNOSTIC_TEST

Thermodilution based assessment of coronary microcirculation

Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Roberto Scarsini, MD PhD · Azienda Ospedaliera Universitaria di Verona

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2026-01-31
Completion
2030-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356727 on ClinicalTrials.gov