Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT07114757
Brief 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. 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:
NCT07114757
Study Brief:
Protocol Section:
NCT07114757