2023 ESC Guidelines for the management of cardiomyopathies.
Elena Arbelo, Alexandros Protonotarios, Juan R Gimeno...
https://pubmed.ncbi.nlm.nih.gov/37622657Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06356727
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2024-04-10
190
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Universitaria Integrata Verona
Lead Sponsor
A
Abbott Medical Devices
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating patients with idiopathic dilated cardiomyopathy and left ventricular dysfunction (LVEF ≤40%) who have not yet received anti-remodeling cardiac therapy. The study aims to assess coronary microvascular function using a thermodilution-based invasive method and evaluate how this relates to left ventricular reverse remodeling after 12 months of optimal medical treatment. This prospective, multicenter, single-arm study also seeks to monitor patients for up to 5 years to understand their clinical outcomes better. Participants will undergo coronary angiography to exclude obstructive coronary artery disease and receive fractional flow reserve (FFR) measurement. Microvascular parameters such as coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and microvascular resistance reserve (MRR) will be assessed using a pressure/thermodilution guidewire. Hyperemia will be induced by intravenous adenosine or intracoronary papaverine as part of standard care. After baseline assessments, patients will receive optimal medical therapy guided by a heart failure team, with follow-up echocardiography at 12 months to evaluate changes in cardiac remodeling. During the study, participants will have various diagnostic tests including ECG telemetry or Holter monitoring for arrhythmia detection, cardiopulmonary exercise testing for functional capacity, blood tests (NT-proBNP), and contrast-enhanced cardiac magnetic resonance imaging (CMR), which may be repeated after 12 months. Genetic counseling and testing are recommended per guidelines. The primary outcome is the rate of left ventricular reverse remodeling after one year, with secondary outcomes including adverse cardiac events over five years and functional and imaging changes. The study includes comprehensive monitoring and data collection to understand disease progression and treatment effects.
CONDITIONS
Brief Title
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged over 18 years
- First diagnosis of idiopathic dilated cardiomyopathy with LVEF 40% or less
- Clinical indication for diagnostic coronary angiography
- Able and willing to provide informed consent
You will not qualify if you...
- Obstructive coronary artery disease or angiographic severe disease in epicardial vessels
- History of myocardial infarction, percutaneous revascularization, or coronary bypass surgery
- Valvular heart diseases such as severe aortic stenosis or regurgitation, severe primary mitral regurgitation
- Infective endocarditis
- Congenital heart disease
- Peripartum cardiomyopathy
- Acute myocarditis or pericarditis
- Persistent high-rate supraventricular arrhythmias
- Excessive alcohol intake over 80 g/day for at least five years
- Previous chemotherapy with certain drugs above specified doses
- Uncontrolled high blood pressure over 160/100 mmHg
- Severe chronic kidney disease (stage IV or V)
- Allergy or contraindication to iodinated contrast or adenosine
- Chronic resting oxygen saturation below 85%
- Pregnancy or suspected pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Diagnostic Evaluation
Duration - After acute heart failure treatment phase; typically within weeks after enrollment
Participants undergo coronary angiography and microvascular assessment using a pressure/thermodilution guidewire to evaluate coronary microcirculation.
1 in-person visit for coronary angiography and microvascular assessment
Monitoring
Duration - 12 months for primary outcome assessment; clinical follow-up up to 5 years
Participants are managed by a dedicated heart failure team to optimize medical therapy and undergo diagnostic tests such as echocardiography, ECG monitoring, cardiopulmonary exercise testing, cardiac magnetic resonance imaging, and genetic counseling as per clinical guidelines.
Multiple visits including baseline and 12-month echocardiography; clinical follow-up visits as per routine care over 5 years
Trial Site Locations
Total: 9 locations
1
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Not Yet Recruiting
2
Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino
Genova, Italy
Not Yet Recruiting
3
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
4
Ospedale Galeazzi di Sant'Ambrogio IRCCS
Milan, Italy
Not Yet Recruiting
5
University of Naples Federico II
Naples, Italy
Not Yet Recruiting
6
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Not Yet Recruiting
7
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy
Not Yet Recruiting
8
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Not Yet Recruiting
9
Azienda Ospedaliera Universitaria di Verona
Verona, Italy, 37126
Actively Recruiting
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Research Team
N
Natascia Antonioli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Published Research Related To This Trial
2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure.
Theresa A McDonagh, Marco Metra, Marianna Adamo...
https://pubmed.ncbi.nlm.nih.gov/34447992Prevalence and prognostic significance of left ventricular reverse remodeling in dilated cardiomyopathy receiving tailored medical treatment.
Marco Merlo, Stylianos A Pyxaras, Bruno Pinamonti...
https://pubmed.ncbi.nlm.nih.gov/21435516Patient profiling in heart failure for tailoring medical therapy. A consensus document of the Heart Failure Association of the European Society of Cardiology.
Giuseppe M C Rosano, Brenda Moura, Marco Metra...
https://pubmed.ncbi.nlm.nih.gov/33932268Coronary Microvascular Dysfunction Across the Spectrum of Cardiovascular Diseases: JACC State-of-the-Art Review.
Marco Giuseppe Del Buono, Rocco A Montone, Massimiliano Camilli...
https://pubmed.ncbi.nlm.nih.gov/34556322Microvascular Dysfunction in Dilated Cardiomyopathy: A Quantitative Stress Perfusion Cardiovascular Magnetic Resonance Study.
Ankur Gulati, Tevfik F Ismail, Aamir Ali...
https://pubmed.ncbi.nlm.nih.gov/30660522