The TARGET BP OFF-MED Trial

  • Research type

    Research Study

  • Full title

    A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension, in the Absence of Antihypertensive Medications

  • IRAS ID

    250980

  • Contact name

    Melvin Lobo

  • Contact email

    m.d.lobo@qmul.ac.uk

  • Sponsor organisation

    Ablative Solutions, Inc.

  • Eudract number

    2018-000036-96

  • Clinicaltrials.gov Identifier

    NCT03503773

  • Duration of Study in the UK

    3 years, 6 months, 1 days

  • Research summary

    High blood pressure affects over 25% adults and is implicated in 62% of heart disease and 49% of coronary heart disease. Current treatment options include oral anti-hypertensive medications. However, a large proportion of patients do not achieve adequate blood pressure control. The difficulty in treating hypertension, its high prevalence and severe consequences, and the limitations of purely pharmacologic approaches, have prompted the development of other interventional approaches.

    This is a Phase 2, prospective, randomized, blinded, sham procedure-controlled, multicenter trial to assess the efficacy and safety of the destruction of nervous tissue around the kidney artery with alcohol using the Peregrine Kit. This will be an “off medication” study to confirm the basic hypothesis that destruction of nervous tissue around the kidney artery using the Peregrine Catheter and alcohol will lower the blood pressure in subjects with high blood pressure without medication.

    The investigational product is a co-packaged combination product, the Peregrine System™ Kit. This contains a device component, the Peregrine System™ Infusion Catheter, and a drug component, Dehydrated Alcohol Injection, USP.

    Subjects who are taking 0, 1, or 2 anti-hypertensive medications at enrollment will be recruited. It is planned to screen approximately 400 male and female subjects, aged ≥18 and ≤80 years, in order to randomize approximately 90 subjects.

    The trial will include approximately 18 investigational sites in the EU.

    The planned duration of the study is approximately 3.5 years. The planned duration of participation is approximately 26 months for each subject (including screening, run-in, and follow-up assessments). In the case of crossover, the duration of the study may be different for subjects in the Sham Control Arm (maximum approximately 33 months).

  • REC name

    London - London Bridge Research Ethics Committee

  • REC reference

    18/LO/2006

  • Date of REC Opinion

    14 Feb 2019

  • REC opinion

    Further Information Favourable Opinion