NCT05994729Not yet recruiting
Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale
Source: ClinicalTrials.gov · Last updated 24 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Aurelia Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05994729
What you commit to
- Study type: Interventional
- Planned participants: 87
- From 1 Jan 2024 to the primary completion date, 1 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Rul-in Phase Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- Refuse to sign informed consent
- Evidence of newly detected obstructive CAD on invasive coronary angiography performed 6 months after RDN
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.