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)

Phase 4

Terminated

• Conditions: Resistant Hypertension
• Interventions: Drug: adenosine infusion treatment; Procedure: Renal denervation

• Registration Number: NCT01918111
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-09
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2016-05-27
• Study Completion: 2016-05-27
• Status Verified: 2016-12
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	adenosine infusion treatment	Control group
RD group	Renal denervation	Renal denervation group

Primary Outcome Measures

Name	Time	Method
Change in coronary atheroma	change in coronary atheroma for 24 months after renal denervation	Evaluation of the change in coronary atheroma (change in percent atheroma volume (PAV) and the change in nominal atheroma volume in the 10-mm subsegment with the greatest disease severity at baseline), analyzed by an IVUS, between baseline and 2-year IVUS in the patients with CAD) for RENEWAL-REGRESS trial

Secondary Outcome Measures

Name	Time	Method
Reduction of peak exercise E/E prime	Peak exercise E/E prime from 6 and 12 months after renal denervation	Reduction of peak exercise E/E prime at 6 month follow up for RENEWAL-EXERCISE trial

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of