Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale (IMPRESSION)
Coronary Microvascular Dysfunction, Resistant Hypertension, Hypertensive Heart Disease
About this trial
This is an interventional treatment trial for Coronary Microvascular Dysfunction focused on measuring MVD, HHD
Eligibility Criteria
Rul-in Phase Inclusion Criteria: Non obstructive stable coronary artery disease (CAD) on invasive coronary angiography (defined as the absence of either >50% angiographic stenosis or any flow limiting lesion on functional evaluation) Suspected diagnosis of difficult to control/ resistant hypertension for which renal denervation by radiofrequency ablation with Spyral Symplicity 3 could be considered. Rule-in Phase Exclusion Criteria: Initiation of either nitrates, beta-blocker or calcium channel blocker less than 30 days before the end of the rule-in phase Physiological assessment performed during first medical contact documenting preserved coronary microvascular function Physiological assessment performed at the "first contact" hospitalization followed by modification of medical therapy during the rule-in phase, before RDN Acceptable blood pressure control after medical treatment optimization Identification of secondary causes of hypertension Renal artery anatomy not suitable for RDN Ejection fraction below 30% Life expectancy below 1 year Indication to cardiac surgery Adenosine allergy Pregnancy Large necrotic area documented by either MRI, SPECT or combination of ECG signs + Echocardiographic images. Hemodynamic instability Refuse to sign informed consent Age below 18 or above 80 Study Phase Inclusion Criteria: Having coronary microvascular dysfunction documented by invasive functional assessment (IMR>25 and or CFR < 2) Fulfilling all the rule-in phase inclusion criteria without any rule-in phase exclusion criteria Study Phase Exclusion Criteria: Refuse to sign informed consent Evidence of newly detected obstructive CAD on invasive coronary angiography performed 6 months after RDN
Sites / Locations
Arms of the Study
Arm 1
Experimental
Candidates to RDN with ascertained CMD
Patients that are candidates to receive RDN for resistant/difficult to control hypertension, who also have documented coronary microvascular dysfunction