Status:
NOT_YET_RECRUITING
Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale
Lead Sponsor:
Aurelia Hospital
Conditions:
Coronary Microvascular Dysfunction
Resistant Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
The aim of this study is to evaluate the effect of radiofrequency RDN performed with Spyral Symplicity 3 on microvascular function in patients with ascertained hypertension related coronary microvascu...
Eligibility Criteria
Inclusion
- Rul-in Phase
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT05994729
Start Date
January 1 2024
End Date
December 31 2026
Last Update
October 24 2023
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