Back to resultsEffects 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)
Primary Purpose
Resistant Hypertension
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renal denervation
adenosine infusion treatment
Sponsored by
About this trial
This is an interventional treatment trial for Resistant Hypertension focused on measuring Renal denervation, Exercise diastolic function, Atherosclerosis, New methods
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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RD group
Control group
Arm Description
Renal denervation group
Control group
Outcomes
Primary Outcome Measures
Change in coronary atheroma
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
Reduction of peak exercise E/E prime
Reduction of peak exercise E/E prime at 6 month follow up for RENEWAL-EXERCISE trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01918111
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The study terminated early due to the difficulty of recruiting candidates.
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 27, 2016 (Actual)
Study Completion Date
May 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
(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.
(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.
(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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension
Keywords
Renal denervation, Exercise diastolic function, Atherosclerosis, New methods
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RD group
Arm Type
Experimental
Arm Description
Renal denervation group
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
Renal denervation
Intervention Description
Renal denervation will be performed via common femoral artery with standard endovascular technique and simplicity catheter
Intervention Type
Drug
Intervention Name(s)
adenosine infusion treatment
Intervention Description
Continue hypertensive medication
Primary Outcome Measure Information:
Title
Change in coronary atheroma
Description
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
Time Frame
change in coronary atheroma for 24 months after renal denervation
Secondary Outcome Measure Information:
Title
Reduction of peak exercise E/E prime
Description
Reduction of peak exercise E/E prime at 6 month follow up for RENEWAL-EXERCISE trial
Time Frame
Peak exercise E/E prime from 6 and 12 months after renal denervation
Other Pre-specified Outcome Measures:
Title
Evaluation of the novel methods predicting the successful renal sympathetic denervation after RDN
Description
Evaluation of the novel methods predicting the successful or unsuccessful renal sympathetic denervation after RDN: 1) Effects the change of blood pressure by infusion of intra-renal adenosine at pre- and immediate post-RND on blood pressure at 6 and 12 months; 2) Association of skin sympathetic activity measurement before and immediate post-procedure and blood pressure at 6 and 12 months; RENEWAL-PREDICT trial)
Time Frame
change of blood pressure at 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
34806762
Citation
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.
Results Reference
derived
Learn more about this trial
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)
We'll reach out to this number within 24 hrs