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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01918111
• Date of registration: 09/07/2013
• Prospective Registration: Yes
• Primary sponsor: Yonsei University
• Public 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)
• Date of first enrolment: August 2013
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01918111
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Resistant Hypertension

Intervention(s)

Procedure: Renal denervation

Drug: adenosine infusion treatment

Primary Outcome(s)

Change in coronary atheroma [Time Frame: change in coronary atheroma for 24 months after renal denervation]

Secondary Outcome(s)

Reduction of peak exercise E/E prime [Time Frame: Peak exercise E/E prime from 6 and 12 months after renal denervation]

Secondary ID(s)

1-2013-0025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors