An interventional study of Thermodilution based assessment of coronary microcirculation in Heart Failure, Left Ventricular Dysfunction and Idiopathic Dilated Cardiomyopathy, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Active, not recruiting at 12 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Supportive care
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.
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 ≤ 0.80 will be considered abnormal. Microvascular assessment will be performed using the same pressure/thermodilution 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:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 200 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Coronary microvascular assessment
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.
Rate of Left ventricular reverse remodeling (LVRR)
LVRR, defined as LVEF increase ≥ 10% and LVEDDi decrease ≥ 10%, will be assessed with transthoracic echocardiography and analyzed off-line by an independent central corelab.
Time frame: After 12 months of guidelines directed optimal medical therapy
Adverse clinical events
Composite of cardiovascular death, new hospitalization for HF, ICD implantation, heart transplantation or ventricular mechanical assistance implantation during follow-up in patients with and without coronary microvascular dysfunction
Time frame: Up to 5 years
Rate of LVRR at cardiac magnetic resonance
LVRR, defined as LVEF increase ≥ 10% and LVEDDi decrease ≥ 10%, in patients who will undergo CMR at baseline and at 12 months follow up.
Time frame: After 12 months of guidelines directed OMT
Changes in functional capacity at cardiopulmonary exercise test
Variations of VO2 max at CPET after 12 months of guidelines-defined OMT
Time frame: After 12 months of guidelines-defined OMT
Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling.
CMD endotypes
Time frame: At baseline
Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance.
Measures of LV adverse remodeling at CMR
Time frame: At baseline
Plan to share: Yes — Yes.
Supporting information: Study protocol
Time frame: The present study is powered for assessing left ventricular reverse remodeling in patients with and without coronary microvascular dysfunction. However, the study is not powered for clinical adverse events. In order to obtain compelling evidence on this latter endpoint, the data of the present study will be merged with those of clinical studies sharing the same inclusion and exclusion criteria and study interventions. Data will be available for individual patient level analysis in order to merge our data with other studies sharing inclusion and exclusion criteria. Data will be available after the completion of the primary endpoint.
Access criteria: Direct request to study Principal Investigator.
Started Jan 2024 (actual). Primary completion is estimated for Sep 2027, 43 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 43 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
Primary completion moved once since we started tracking on Sep 25, 2026: Jan 2026 → Sep 2027, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Integrata Verona