Coronary Microvascular DysfunctionIMPRESSIONNCT05994729
Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale
A study testing Invasive Physiological Assessment of Coronary Circulation in people with Coronary Microvascular Dysfunction and Resistant Hypertension, run by Aurelia Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Microvascular Dysfunction, Resistant Hypertension, Hypertensive Heart Disease
- What is being tested?
- Invasive Physiological Assessment of Coronary Circulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Invasive Physiological Assessment of Coronary Circulation
- Keywords
- MVD, HHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive Physiological Assessment of Coronary CirculationDiagnostic test
Also called CFR, IMR, Tmn
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Invasive Physiological Assessment of Coronary Circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microvascular resistance (IMR)
Matched comparison of IMR from baseline to 12 months after RDN
Measured: 12 months
Secondary outcomes (9)
Coronary Flow Reserve (CFR)
Matched comparison of CFR from baseline to 12 months after RDN
Measured: 12 months
Mean transit time (TMN)
Matched comparison of both resting and hyperemic TMN from baseline to 12 months after RDN
Measured: 12 months
Systolic Blood Pressure (BP) on Ambulatory blood pressure monitoring (ABPM)
Matched Comparison of Average Systolic Blood Pressure measured on 24 hour Ambulatory Blood Pressure Monitoring
Measured: 12 Months
Diastolic BP on ABPM
Matched Comparison of Average Systolic Blood Pressure measured on 24 hour Ambulatory Blood Pressure Monitoring
Measured: 12 Months
Average BP on ABPM
Matched Comparison of Average Mean Blood Pressure measured on 24 hour Ambulatory Blood Pressure Monitoring
Measured: 12 Months
Time in Therapeutic BP Range
Matched Comparison of total time spent with both systolic and diastolic BP within normality range measured on 24 hour Ambulatory Blood Pressure Monitoring
Measured: 12 Months
BP Medication Burden
Matched Comparison of Total Number of BP medication prescribed to the subject
Measured: 12 Months
Mini-SAQ Score (Seattle Angina Questionnaire)
Matched Comparison of Average Score on Mini Seattle Angina Questionnaire (SAQ)
Measured: 12 Months
NTproBNP
Matched Comparison of Average NTproBNP
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurelia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Tomai, MD, FACC, FESC, Principal investigator, Aurelia Hospitalstefano migliaro, MD, Study chair, Aurelia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994729
- Sponsor's protocol ID
- AH Card. 08-23
- Acronym
- IMPRESSION
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renal Denervation in Patients With Coronary Microvascular Dysfunction: Study Design and Rationale
- ClinicalTrials.gov ID
- NCT05994729
- Acronym / sponsor ID
- IMPRESSION / AH Card. 08-23
- Keywords
- MVD, HHD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Aurelia HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates to RDN with ascertained CMD | Experimental | Diagnostic Test: Invasive Physiological Assessment of Coronary CirculationPatients that are candidates to receive RDN for resistant/difficult to control hypertension, who also have documented coronary microvascular dysfunction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive Physiological Assessment of Coronary CirculationAlso: CFR, IMR, TmnAfter 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. | Diagnostic test | Candidates to RDN with ascertained CMD |
Primary outcome
Index of microvascular resistance (IMR)
Time frame: 12 months
Matched comparison of IMR from baseline to 12 months after RDN
9 secondary outcomes
Coronary Flow Reserve (CFR)
Time frame: 12 months
Mean transit time (TMN)
Time frame: 12 months
Systolic Blood Pressure (BP) on Ambulatory blood pressure monitoring (ABPM)
Time frame: 12 Months
Diastolic BP on ABPM
Time frame: 12 Months
Average BP on ABPM
Time frame: 12 Months
Time in Therapeutic BP Range
Time frame: 12 Months
BP Medication Burden
Time frame: 12 Months
Mini-SAQ Score (Seattle Angina Questionnaire)
Time frame: 12 Months
NTproBNP
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrizio Tomai, MD, FACC, FESC principal investigator
Aurelia Hospital
stefano migliaro, MD study chair
Aurelia Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Invasive Physiological Assessment of Coronary Circulation in people with Coronary Microvascular Dysfunction and Resistant Hypertension, run by Aurelia Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Tomai, MD, FACC, FESC (0039 06 65975725, fabriziotomai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of microvascular resistance (IMR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.