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)

NCT ID: NCT01918111

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-05-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RD group

Renal denervation group

Group Type: EXPERIMENTAL

Renal denervation

Intervention Type: PROCEDURE

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

Control group

Control group

Group Type: ACTIVE_COMPARATOR

adenosine infusion treatment

Intervention Type: DRUG

Continue hypertensive medication

Interventions

Renal denervation

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

Intervention Type: PROCEDURE

adenosine infusion treatment

Continue hypertensive medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 20-85 years with resistant hypertension defined as systolic BP>140 mmHg (>130 mmHg for diabetes) or diastolic BP>90mmHg (>80 mmHg for diabetes) despite adequate administration of 3 or more different classes of anti-hypertensive medications including diuretics with good adherence and adequate treatment regimen.
• All agents should be prescribed at optimal dose amounts. BP was based on an average of 3 office BP readings measured according to the general guidelines. Patients are adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment).
• Patients provided with the written, informed consent to participate in this study

Exclusion Criteria

• Hemodynamically or anatomically significant renal artery abnormalities, main renal arteries < 4 mm in diameter or < 20 mm in length, or.prior renal artery intervention
• Estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation
• Hemodynamically significant valvular heart disease
• History of congestive heart failure with reduce LV ejection fraction of less than 35%
• CVA in the prior 3 months
• ST-segment elevation MI within 48 hours
• Scheduled or planned surgery or cardiovascular intervention in the next 6 months.
• Patients with chronic debilitating disease with life expectancy of less than 1 year
• Patients taking hormone replace treatment and/or oral contraceptives; pregnant, nursing or planning to be pregnant
• Chronic liver cirrhosis

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

References

Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3.

Reference Type: DERIVED

PMID: 34806762 (View on PubMed)

Other Identifiers

1-2013-0025

Identifier Type: -

Identifier Source: org_study_id