Status:
TERMINATED
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)
Lead Sponsor:
Yonsei University
Conditions:
Resistant Hypertension
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
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 pathogen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01918111
Start Date
August 1 2013
End Date
May 27 2016
Last Update
March 28 2019
Active Locations (1)
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1
Severance hospital
Seoul, South Korea, 120-752