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Renal Denervation in Refractory Hypertension

NCT01560312 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-02-01

No results posted yet for this study

Summary

Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.

Conditions

Interventions

DEVICE

Renal denervation (Symplicity® Catheter System™)

4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)

Sponsors & Collaborators

  • General University Hospital, Prague

    collaborator OTHER

  • University Hospital Olomouc

    collaborator OTHER

  • Cardiocenter Podlesí, Trinec, Czech Republic

    collaborator UNKNOWN

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Petr Widimsky, Prof, MD · Charles University, Prague, Czech Republic

  • Jiri Widimsky, Prof.MD. · General University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560312 on ClinicalTrials.gov