Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356727
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-30
Brief Title:
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICROREV
Brief 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
Detailed Description:
This is a prospective multicentric single-arm explorative clinical study in patients presenting with heart failure and idiopathic dilated cardiomyopathy with LVEF 40 Patients identified as eligible for the protocol will be asked for written informed consent to participate in the study
After appropriate treatment of the acute heart failure phase participants will undergo coronary angiography to rule out obstructive coronary disease
Fractional flow reserve FFR will be assessed as per standard clinical practice and a value 080 will be considered abnormal Microvascular assessment will be performed using the same pressurethermodilution guidewire used for FFR assessment with the derivation of coronary flow reserve CFR index of microcirculatory resistance IMR and the microvascular resistance reserve MRR
Steady-state hyperemia will be obtained using an intravenous adenosine infusion or intracoronary papaverine as per routine clinical practice
The primary endpoint will be assessed based on the variation of echocardiographic indices from the baseline to 12-month follow up Transthoracic echocardiography will be performed to confirm the diagnosis and obtain information about adverse cardiac remodeling and after 12 months of optimal medical therapy to evaluate reverse remodeling
Patients will be clinically managed by a dedicated heart failure team to optimize medical therapy and organize the follow-up
Patients enrolled in the study will be clinically followed for a period of 5 years to monitor the clinical status and report major adverse cardiac events
During the study period participants may undergo multimodality diagnostic tests according to the recent international guidelines Data from these tests will be collected if the test will be performed per clinical practice
1 3-leads ECG telemetry monitoring or 24 hours Holter ECG to detect or quantify atrial andor ventricular arrhythmias during the hospitalization
2 N-terminal pro-B-type natriuretic peptide NT - proBNP
3 Cardiopulmonary exercise testing CPET to assess functional capacity
4 Contrast enhanced cardiac magnetic resonance CMR assessment may be repeated at 12 months follow-up
5 Genetic counseling and genetic testing performed by an appropriately trained healthcare professional is recommended in patients with idiopathic DCM by the latest international guidelines to enable diagnosis prognostication therapeutic stratification
After appropriate treatment of the acute heart failure phase participants will undergo coronary angiography to rule out obstructive coronary disease
Fractional flow reserve FFR will be assessed as per standard clinical practice and a value 080 will be considered abnormal Microvascular assessment will be performed using the same pressurethermodilution guidewire used for FFR assessment with the derivation of coronary flow reserve CFR index of microcirculatory resistance IMR and the microvascular resistance reserve MRR
Steady-state hyperemia will be obtained using an intravenous adenosine infusion or intracoronary papaverine as per routine clinical practice
The primary endpoint will be assessed based on the variation of echocardiographic indices from the baseline to 12-month follow up Transthoracic echocardiography will be performed to confirm the diagnosis and obtain information about adverse cardiac remodeling and after 12 months of optimal medical therapy to evaluate reverse remodeling
Patients will be clinically managed by a dedicated heart failure team to optimize medical therapy and organize the follow-up
Patients enrolled in the study will be clinically followed for a period of 5 years to monitor the clinical status and report major adverse cardiac events
During the study period participants may undergo multimodality diagnostic tests according to the recent international guidelines Data from these tests will be collected if the test will be performed per clinical practice
1 3-leads ECG telemetry monitoring or 24 hours Holter ECG to detect or quantify atrial andor ventricular arrhythmias during the hospitalization
2 N-terminal pro-B-type natriuretic peptide NT - proBNP
3 Cardiopulmonary exercise testing CPET to assess functional capacity
4 Contrast enhanced cardiac magnetic resonance CMR assessment may be repeated at 12 months follow-up
5 Genetic counseling and genetic testing performed by an appropriately trained healthcare professional is recommended in patients with idiopathic DCM by the latest international guidelines to enable diagnosis prognostication therapeutic stratification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None