Cardiovascular DiseasesREDsNCT07114757
REnal Denervation After Stroke (REDs) Study - A Randomized Clinical Trial of Renal Denervation in the Subacute Phase of Stroke
A study testing Renal denervation after stroke in people with Cardiovascular Diseases and Cerebrovascular Disease, run by Centro per la Lotta Contro l'Infarto - Fondazione Onlus at 1 site in Italy.
Trial summary
The REnal Denervation after stroke (REDs) study is a national, multicenter, investigator-initiated randomized controlled clinical trial designed to assess the efficacy of catheter-based renal denervation (RDN) performed in the subacute phase of stroke among patients with drug-resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Disease, Arterial Hypertension
- What is being tested?
- Renal denervation after stroke
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2025to 25 Sep 2029
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will enroll patients (at least 18 years of age and younger than 85 years old) with subacute stroke (thus occurring 7-45 days before screening), admitted to hospital, with persistently high systolic PB (≥140 mm Hg computed as the mean of 3 repeated measurements taken within 5 minutes between 8.00am and 8.30 am on 2 consecutive days, thus totaling 6 measurements), or a non-dipper profile at ambulatory BP monitoring, despite therapy with ≥2 anti-hypertensive drugs at maximum tolerated dose. Patients should be medically stable with no severe complications such as infections, or worsening of neurological status that would require immediate and intensive medical or surgical intervention.
Who cannot join
- ⦁ Patients with cerebral bleeding due to arteriovenous malformation or intracranial aneurysm
- Hemodynamic instability
- Comorbidity with life expectancy ≤ 1 year
- Renal artery anatomy, which prevents the procedure
- Reno vascular disease
- Vascular occlusion, which prevents the procedure
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- Secondary hypertension
- Subject has known hypersensitivity or contraindication to any of the study drugs
- The subject is currently participating in another investigational drug or device clinical study
- Pregnancy or nursing
- Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements or impact the scientific soundness of the clinical investigation results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The REnal Denervation after stroke (REDs) study is a national, multicenter, investigator-initiated randomized controlled clinical trial designed to assess the efficacy of catheter-based renal denervation (RDN) performed in the subacute phase of stroke among patients with drug-resistant hypertension. Conducted across 15 Italian centers, this pragmatic trial adopts a parallel-group design with participants randomized in a 1:1 ratio to receive either RDN using the Symplicity Spyral system or standard care. Randomization will occur via a secure online platform, and the intervention will be performed within 24 hours post-randomization, adhering to a standardized procedural protocol.
The trial targets adult patients aged 18 to 84 years who have experienced a stroke 7 to 45 days prior to enrollment and present with persistent systolic hypertension (≥140 mmHg) or a non-dipping profile on ambulatory blood pressure monitoring, despite the use of at least two antihypertensive medications at maximum tolerated doses. Following informed consent and verification of eligibility, enrolled patients will undergo baseline assessments including physical examination, laboratory testing, ECG, stroke severity and disability scoring, and quality of life evaluation.
Read more
The total duration of the REDs study is 48 months, encompassing a 24-month enrollment window and a 24-month follow-up period. Study endpoints, including 24-hour ambulatory blood pressure and secondary clinical and functional outcomes, will be evaluated at 3, 6, 9, 12, and 24 months following the intervention. These follow-up assessments will be conducted through hospital visits or teleconsultations as appropriate.
The primary efficacy endpoint is the change in mean 24-hour systolic blood pressure 12 months after randomization. Secondary endpoints include diastolic and mean arterial pressure, antihypertensive medication burden, time to blood pressure control, functional neurological scores (NIHSS, mRS), quality of life metrics, and stroke recurrence. Data collection will be managed via an electronic case report form (eCRF), and adverse events will be monitored throughout the study in line with ISO14155 and GCP standards.
This trial is supported by an unrestricted grant from Medtronic and adheres to ethical guidelines as outlined by the Declaration of Helsinki and GDPR. The REDs study aims to generate clinically relevant evidence to support the integration of RDN into secondary prevention strategies for stroke patients with resistant hypertension.
- Conditions
- Cardiovascular Diseases, Cerebrovascular Disease, Arterial Hypertension, Hypertension, Renal Denervation, Stroke
- Being tested
- Renal denervation after stroke
- Medical subject headings
- Cardiovascular Diseases, Cerebrovascular Disorders, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation after strokeProcedure or surgery
Renal sympathetic denervation (RDN) is a minimally invasive catheter-based procedure targeting renal sympathetic nerve fibers to achieve sustained reductions in blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| RDN | Experimental | This arm includes the patients who will be treated with renal denervation. Receives: Procedure: Renal denervation after stroke |
| Standard therapy | No intervention | This arm includes the patients who will be treated with standard therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean 24-hour systolic blood pressure 12 months after randomization
mean 24-hour systolic blood pressure 12 months after randomization
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 posted11 Aug 2025
- Study start25 Sep 2025 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion25 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro per la Lotta Contro l'Infarto - Fondazione Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Versaci, Ospedale Santa Maria Goretti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114757
- Sponsor's protocol ID
- REDs
- Acronym
- REDs
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REnal Denervation After Stroke (REDs) Study - A Randomized Clinical Trial of Renal Denervation in the Subacute Phase of Stroke
- ClinicalTrials.gov ID
- NCT07114757
- Acronym / sponsor ID
- REDs / REDs
- Conditions
- Cardiovascular Diseases, Cerebrovascular Disease, Arterial Hypertension, Hypertension, Renal Denervation, Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centro per la Lotta Contro l'Infarto - Fondazione OnlusUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 25 Sep 2029 (estimated)
- First posted
- 11 Aug 2025 (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.
The REnal Denervation after stroke (REDs) study is a national, multicenter, investigator-initiated randomized controlled clinical trial designed to assess the efficacy of catheter-based renal denervation (RDN) performed in the subacute phase of stroke among patients with drug-resistant hypertension. Conducted across 15 Italian centers, this pragmatic trial adopts a parallel-group design with participants randomized in a 1:1 ratio to receive either RDN using the Symplicity Spyral system or standard care. Randomization will occur via a secure online platform, and the intervention will be performed within 24 hours post-randomization, adhering to a standardized procedural protocol.
The trial targets adult patients aged 18 to 84 years who have experienced a stroke 7 to 45 days prior to enrollment and present with persistent systolic hypertension (≥140 mmHg) or a non-dipping profile on ambulatory blood pressure monitoring, despite the use of at least two antihypertensive medications at maximum tolerated doses. Following informed consent and verification of eligibility, enrolled patients will undergo baseline assessments including physical examination, laboratory testing, ECG, stroke severity and disability scoring, and quality of life evaluation.
The total duration of the REDs study is 48 months, encompassing a 24-month enrollment window and a 24-month follow-up period. Study endpoints, including 24-hour ambulatory blood pressure and secondary clinical and functional outcomes, will be evaluated at 3, 6, 9, 12, and 24 months following the intervention. These follow-up assessments will be conducted through hospital visits or teleconsultations as appropriate.
The primary efficacy endpoint is the change in mean 24-hour systolic blood pressure 12 months after randomization. Secondary endpoints include diastolic and mean arterial pressure, antihypertensive medication burden, time to blood pressure control, functional neurological scores (NIHSS, mRS), quality of life metrics, and stroke recurrence. Data collection will be managed via an electronic case report form (eCRF), and adverse events will be monitored throughout the study in line with ISO14155 and GCP standards.
This trial is supported by an unrestricted grant from Medtronic and adheres to ethical guidelines as outlined by the Declaration of Helsinki and GDPR. The REDs study aims to generate clinically relevant evidence to support the integration of RDN into secondary prevention strategies for stroke patients with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDN | Experimental | Procedure: Renal denervation after strokeThis arm includes the patients who will be treated with renal denervation. |
| Standard therapy | No intervention | –This arm includes the patients who will be treated with standard therapy. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will enroll patients (at least 18 years of age and younger than 85 years old) with subacute stroke (thus occurring 7-45 days before screening), admitted to hospital, with persistently high systolic PB (≥140 mm Hg computed as the mean of 3 repeated measurements taken within 5 minutes between 8.00am and 8.30 am on 2 consecutive days, thus totaling 6 measurements), or a non-dipper profile at ambulatory BP monitoring, despite therapy with ≥2 anti-hypertensive drugs at maximum tolerated dose. Patients should be medically stable with no severe complications such as infections, or worsening of neurological status that would require immediate and intensive medical or surgical intervention.
Key exclusion criteria (11 listed)
- ⦁ Patients with cerebral bleeding due to arteriovenous malformation or intracranial aneurysm
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 |
|---|---|---|
| Renal denervation after strokeRenal sympathetic denervation (RDN) is a minimally invasive catheter-based procedure targeting renal sympathetic nerve fibers to achieve sustained reductions in blood pressure. | Procedure or surgery | RDN |
Primary outcome
mean 24-hour systolic blood pressure 12 months after randomization
Time frame: 12 months
mean 24-hour systolic blood pressure 12 months after randomization
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 11 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation after stroke in people with Cardiovascular Diseases and Cerebrovascular Disease, run by Centro per la Lotta Contro l'Infarto - Fondazione Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Francesco Versaci (+39 0865 442314, francescoversaci@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean 24-hour systolic blood pressure 12 months after randomization (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 11 Aug 2025.