Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994729
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-08-09
Brief Title:
Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction Study Design and Rationale
Sponsor:
Aurelia Hospital
Organization:
Aurelia Hospital
Study Overview
Official Title:
Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction Study Design and Rationale
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRESSION
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 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
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None