Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale

Launched by AURELIA HOSPITAL · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is examining the effects of a procedure called renal denervation (RDN) on patients who have a specific heart condition known as coronary microvascular dysfunction, which can be linked to high blood pressure that is hard to control. The goal of the study is to see if RDN can improve blood flow in the tiny blood vessels of the heart and help manage high blood pressure better. This trial will involve patients who have resistant hypertension and stable coronary artery disease but not significant blockages in their heart arteries.

To participate, individuals must be between 18 and 80 years old and have documented issues with their coronary microvascular function. They should not have had certain heart medications recently or other conditions that could interfere with the study. If eligible, participants will undergo the RDN procedure and will have their heart's blood vessel function re-evaluated 12 months later. This research could provide valuable insights into new treatment options for those struggling with difficult-to-manage high blood pressure and related heart issues.

Gender

ALL

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