drugset / Trial / NCT02910414
TARGET BP I Clinical Trial
RandomizedParallel-groupTriple-blindTreatment
Summary
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
Timeline
- Start
- 2019-07-22
- Primary completion
- 2023-12
- Completion
- 2026-05
Publications
- Kandzari DE, Weber MA, Pathak A, Zidar JP, Saxena M, David SW, Schmieder RE, Janas AJ, Langer C, Persu A, Mendelsohn FO, Ameloot K, Foster M 3rd, Fischell TA, Parise H, Mahfoud F. Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial. Circulation. 2024 Jun 11;149(24):1875-1884. doi: 10.1161/CIRCULATIONAHA.124.069291. Epub 2024 Apr 8.
- Bertog S, Sharma A, Mahfoud F, Pathak A, Schmieder RE, Sievert K, Papademetriou V, Weber MA, Haratani N, Lobo MD, Saxena M, Kandzari DE, Fischell TA, Sievert H. Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine Infusion Catheter. Cardiovasc Revasc Med. 2021 Mar;24:77-86. doi: 10.1016/j.carrev.2020.09.003. Epub 2020 Sep 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 0.6 ml | Other |