[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515686":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":31,"locations":35,"responsibleParty":40,"collaborators":35,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":35,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":35},{"fullName":5,"class":6},"Aurelia Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Candidates to RDN with ascertained CMD","EXPERIMENTAL","Patients that are candidates to receive RDN for resistant\u002Fdifficult to control hypertension, who also have documented coronary microvascular dysfunction",[13],"Diagnostic Test: Invasive Physiological Assessment of Coronary Circulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],[21,22,23],"CFR","IMR","Tmn",[25,28],{"name":26,"affiliation":5,"role":27},"Fabrizio Tomai, MD, FACC, FESC","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":30},"stefano migliaro, MD","STUDY_CHAIR",[32,37],{"name":26,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","0039 06 65975725",null,"fabriziotomai@gmail.com",{"name":29,"role":33,"phone":38,"phoneExt":35,"email":39},"0039 3453373825","migliaro.stefano@gmail.com",{"type":41,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100515686","impact-of-renal-denervation-in-patients-with-coronary-microvascular-dysfunction-study-design-and-rationale-100515686",false,"NCT05994729","Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale","IMPRESSION","Rul-in Phase Inclusion Criteria:\n\n* 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)\n* Suspected diagnosis of difficult to control\u002F resistant hypertension for which renal denervation by radiofrequency ablation with Spyral Symplicity 3 could be considered.\n\nRule-in Phase Exclusion Criteria:\n\n* Initiation of either nitrates, beta-blocker or calcium channel blocker less than 30 days before the end of the rule-in phase\n* Physiological assessment performed during first medical contact documenting preserved coronary microvascular function\n* Physiological assessment performed at the \"first contact\" hospitalization followed by modification of medical therapy during the rule-in phase, before RDN\n* Acceptable blood pressure control after medical treatment optimization\n* Identification of secondary causes of hypertension\n* Renal artery anatomy not suitable for RDN\n* Ejection fraction below 30%\n* Life expectancy below 1 year\n* Indication to cardiac surgery\n* Adenosine allergy\n* Pregnancy\n* Large necrotic area documented by either MRI, SPECT or combination of ECG signs + Echocardiographic images.\n* Hemodynamic instability\n* Refuse to sign informed consent\n* Age below 18 or above 80\n\nStudy Phase Inclusion Criteria:\n\n* Having coronary microvascular dysfunction documented by invasive functional assessment (IMR\\>25 and or CFR \\\u003C 2)\n* Fulfilling all the rule-in phase inclusion criteria without any rule-in phase exclusion criteria\n\nStudy Phase Exclusion Criteria:\n\n* Refuse to sign informed consent\n* Evidence of newly detected obstructive CAD on invasive coronary angiography performed 6 months after RDN","ALL","18 Years","80 Years",{"count":53,"type":54},87,"ESTIMATED","INTERVENTIONAL",[57],"NA","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.\n\nThis 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.",[60,61,62],"Coronary Microvascular Dysfunction","Resistant Hypertension","Hypertensive Heart Disease",[64,65],"MVD","HHD","NOT_YET_RECRUITING","2023-10-22",{"date":69,"type":70},"2023-10-24","ACTUAL",{"date":72,"type":54},"2024-01-01",{"date":74,"type":54},"2026-12-31",{"name":5,"class":6}]