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Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

ConditionsHeart FailureLeft Ventricular DysfunctionIdiopathic Dilated Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAzienda Ospedaliera Universitaria Integrata Verona

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Obstructive CAD (defined as angiographically intermediate disease [50%-70%] with impaired FFR or as angiographically severe disease [>70%] in 1 or more epicardial vessels)

History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery

Valvular heart disease (rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation)

Infective endocarditis

Trial design

Design model

Single group

Treatments tested in this trial

  • Thermodilution based assessment of coronary microcirculation

    Diagnostic test

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

Treatment groups

190 Participants
are divided into 1 treatment group
Group A: Microvascular assessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling.

CMD endotypes (defined as IMR \>25 units and/or CFR \<2)

Time frame
At baseline

Other outcomes

Sponsors and contacts

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Azienda Ospedaliera Universitaria Integrata Verona

Lead sponsor

Abbott Medical Devices

Collaborator

Source ClinicalTrials.gov
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