NCT05994729

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Aurelia Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

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 microvascular dysfunction (hy-CMD) and/or hypertensive cardiomyopathy. Our hypothesis is that RDN could improve invasive parameters of microvascular function in patients with hy-CMD; these would mean that RDN would be able to at least partially revert the pathogenesis of hy-CMD. The study design comprises an initial rule-in and enrollment phase, required to properly select the target population, followed by the actual study procedural phase. Patients amenable to RDN will be hospitalized and enter the rule-in phase to check for eligibility. Before performing the actual RDN, patients will be asked for the written informed consent to receive physiological evaluation. Only patients that will be diagnosed with hy-CMD will eventually enter the actual study phase. This phase will comprise repeated outpatients visits, according to a predetermined schedule, including a new hospitalization at 12 months to reassess coronary microvascular physiology.

Conditions

• Coronary Microvascular Dysfunction
• Resistant Hypertension
• Hypertensive Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Invasive Physiological Assessment of Coronary Circulation	After 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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-12-31
• First posted: 2023-08-16
• Last updated: 2023-10-24