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

NCT05994729 | Not Yet Recruiting

• 1 other identifier: AH Card. 08-23
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Microvascular Dysfunction; Resistant Hypertension; Hypertensive Heart Disease

Keywords

MVD; HHD

Outcome Measures

Primary Outcomes (1)

• Index of microvascular resistance (IMR)

  Matched comparison of IMR from baseline to 12 months after RDN

  12 months

Secondary Outcomes (9)

• Coronary Flow Reserve (CFR)

  12 months

• Mean transit time (TMN)

  12 months

• Systolic Blood Pressure (BP) on Ambulatory blood pressure monitoring (ABPM)

  12 Months

• Diastolic BP on ABPM

  12 Months

• Average BP on ABPM

  12 Months

Study Arms (1)

Candidates to RDN with ascertained CMD

EXPERIMENTAL

Patients that are candidates to receive RDN for resistant/difficult to control hypertension, who also have documented coronary microvascular dysfunction

Diagnostic Test: Invasive Physiological Assessment of Coronary Circulation

Interventions

Invasive Physiological Assessment of Coronary Circulation DIAGNOSTIC_TEST

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.

Also known as: CFR, IMR, Tmn

Candidates to RDN with ascertained CMD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurelia Hospital: lead

Study Officials

• Fabrizio Tomai, MD, FACC, FESC

  Aurelia Hospital

  PRINCIPAL INVESTIGATOR

• stefano migliaro, MD

  Aurelia Hospital

  STUDY CHAIR

Central Study Contacts

Fabrizio Tomai, MD, FACC, FESC

CONTACT

0039 06 65975725; fabriziotomai@gmail.com

stefano migliaro, MD

CONTACT

0039 3453373825; migliaro.stefano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10