REnal Denervation After Stroke (REDs) Study - A Randomized Clinical Trial of Renal Denervation in the Subacute Phase of Stroke

Launched by CENTRO PER LA LOTTA CONTRO L'INFARTO - FONDAZIONE ONLUS · Aug 4, 2025

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ClinConnect Summary

This clinical trial, called the REDs study, is looking at a treatment called renal denervation (RDN) for people who have had a stroke and still have high blood pressure that is hard to control with medicines. The goal is to find out if this treatment, which uses a small catheter to reduce nerve signals in the kidneys, can help lower blood pressure and improve health outcomes after a stroke. The study involves adults aged 18 to 84 who had a stroke between 7 and 45 days ago and continue to have high blood pressure despite taking at least two blood pressure medications at the highest doses they can tolerate.

If you join this study, you will be randomly assigned to either receive the renal denervation procedure or continue with usual care. Before the treatment, you’ll have some tests to check your health and stroke recovery, including blood pressure monitoring, physical exams, and quality of life assessments. After the treatment, doctors will follow your progress for up to two years, checking your blood pressure and overall health at several points. The study aims to see if renal denervation helps control blood pressure better and reduces the chance of another stroke or other problems. If you have had a recent stroke and struggle with high blood pressure despite treatment, this study might be an option to discuss with your doctor.

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Eligibility criteria

• Inclusion Criteria:
• • - 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.
• Exclusion Criteria:
• • ⦁ 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
• • 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