Overview

This trial is active, not recruiting.

Condition uncontrolled hypertension
Treatment renal denervation (symplicity® renal denervation system)
Sponsor Medtronic Vascular
Start date June 2009
End date September 2010
Trial size 106 participants
Trial identifier NCT00888433, TP-058

Summary

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Renal Denervation and maintenance of anti-hypertensive medications
renal denervation (symplicity® renal denervation system)
Catheter-based renal denervation
(No Intervention)
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

Primary Outcomes

Measure
Office Systolic Blood Pressure Reduction
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics); - on 3 or more antihypertensive medications - >= 18 and =< 85 years of age. Exclusion Criteria: - renal artery abnormalities - eGFR < 45mL/min - MI, angina, CVA within 6 months - Type 1 diabetes - ICD or pacemaker, or any other metallic implant not compatible with MRI - others

Additional Information

Official title Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Principal investigator Murray Esler, MBBS
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Medtronic Vascular.