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Effects of REnal Denervation for Resistant Hypertension on Exercise Diastolic Function and Regression of Atherosclerosis and the Evaluation of NEW Methods Predicting A successfuL Renal Sympathetic Denervation (RENEWAL-EXERCISE, -REGRESS, and -PREDICT Trial From RENEWAL RDN Registry)

NCT01918111 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-03-28

No results posted yet for this study

Summary

1. (RENEWAL-EXERCISE trial) The investigators hypothesize that the increased sympathetic nervous system activation that is associated with resistant hypertension is a major contributor in the pathogenesis of exercise diastolic dysfunction and that modulation of the sympathetic nervous system activity with radiofrequency ablation of the renal artery sympathetic nerve fibers delivered via a treatment catheter, will have a significant effect on the diastolic function that is beyond BP-lowering effect.
2. (RENEWAL-REGRESSION trial) The major cause of mortality and morbidity in hypertension is atherosclerotic cardiovascular disease. the significant decrease in the sympathetic nervous system activation after renal sympathetic denervation will contribute to regression over and beyond it's effect of blood pressure reduction.
3. (RENEWAL-PREDICT trial) No data exists regarding the tests or methods predicting the successful renal denervation causing the effective reduction of BP. For these, the investigators sought to perform the new tests such as adenosine infusion test during procedure and skin sympathetic activity measurement before and immediate post-procedure (detailed explanation provided in section of Methods) and then evaluate the association between these tests and reduction of BP following procedures.

Conditions

  • Resistant Hypertension

Interventions

PROCEDURE

Renal denervation

Renal denervation will be performed via common femoral artery with standard endovascular technique and simplicity catheter

DRUG

adenosine infusion treatment

Continue hypertensive medication

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-05-27
Completion
2016-05-27

Countries

  • South Korea

Study Locations

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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 NCT01918111 on ClinicalTrials.gov