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Renal Denervation in Treatment Resistant Hypertension

NCT01762488 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-05-23

No results posted yet for this study

Summary

The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.

Conditions

Interventions

PROCEDURE

Ablation of the renal arteries

Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.

PROCEDURE

Renal angiography

Renal angiography by femoral access

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Regionshospitalet Silkeborg

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • Central Jutland Regional Hospital

    collaborator OTHER

  • Regional Hospital Holstebro

    collaborator OTHER

  • Henrik Vase

    lead OTHER

Principal Investigators

  • Henrik Vase, MD, PhD · Skejby Hospital, Dept. of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-02-29

Countries

  • Denmark

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 NCT01762488 on ClinicalTrials.gov