Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAurelia Hospital
About this trial
Long-standing hypertension may cause an impairment in microvascular coronary circulation which is involved in many different cardiac conditions. Renal denervation (RDN) has been successfully proven as a valuable and powerful therapeutic choice to consider for patients with resistant hypertension; moreover this procedure looks promising in other cardiac disease such as heart failure and atrial fibrillation, given its ability to downregulate sympathetic nervous system The aim of this study is to explore the effect of renal denervation and blood pressure control on coronary microvascular dysfunction.
This is a multicenter, prospective, non randomized, open-label, interventional study. Consecutive patients with resistant hypertension, non obstructive coronary artery disease and documented microvascular dysfunction will be enrolled. Patients will undergo renal denervation by Spyral Symplicity 3 and re-assessment of coronary microvascular function 12 months after the procedure. Primary endpoint will be the difference in average index of microcirculatory resistance value.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Invasive Physiological Assessment of Coronary Circulation
Diagnostic testAfter 2 months long rule-in phase required to exclude the unsuitable patients, study population will undergo RDN as indicated to treat resistant or difficult to control hypertension; 12 months after RDN, they will undergo invasive physiological study, comprehensive of Coronary Flow Reserve, Index of Microvascular Resistance, Mean Transit Time. These data will be then compared to the baseline ones obtained during the screening phase.
Treatment groups
87 Participants
are divided into 1 treatment groupGroup A: Candidates to RDN with ascertained CMDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Index of microvascular resistance (IMR)
Matched comparison of IMR from baseline to 12 months after RDN
Time frame
12 monthsSecondary outcomes
1
Coronary Flow Reserve (CFR)
Matched comparison of CFR from baseline to 12 months after RDN
Time frame
12 months2
Mean transit time (TMN)
Matched comparison of both resting and hyperemic TMN from baseline to 12 months after RDN
Time frame
12 months3
Systolic Blood Pressure (BP) on Ambulatory blood pressure monitoring (ABPM)
Matched Comparison of Average Systolic Blood Pressure measured on 24 hour Ambulatory Blood Pressure Monitoring
Time frame
12 Months4
Diastolic BP on ABPM
Matched Comparison of Average Systolic Blood Pressure measured on 24 hour Ambulatory Blood Pressure Monitoring
Time frame
12 MonthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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