Resistant HypertensionPhase 4NCT01918111
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)
A Phase 4 study testing Renal denervation and adenosine infusion treatment in people with Resistant Hypertension, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Renal denervation and adenosine infusion treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to 27 May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- (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.
- Conditions
- Resistant Hypertension
- Being tested
- Renal denervation, adenosine infusion treatment
- Keywords
- Renal denervation, Exercise diastolic function, Atherosclerosis, New methods
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
Renal denervation will be performed via common femoral artery with standard endovascular technique and simplicity catheter
adenosine infusion treatmentDrug
Continue hypertensive medication
| Study group | Role | What they receive |
|---|---|---|
| RD group | Experimental | Renal denervation group Receives: Procedure: Renal denervation |
| Control group | Active comparator | Control group Receives: Drug: adenosine infusion treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change in coronary atheroma for 24 months after renal denervation
Secondary outcomes (1)
Reduction of peak exercise E/E prime
Reduction of peak exercise E/E prime at 6 month follow up for RENEWAL-EXERCISE trial
Measured: Peak exercise E/E prime from 6 and 12 months after renal denervation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completion27 May 2016
- Study completion27 May 2016
Why it stopped: The study terminated early due to the difficulty of recruiting candidates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918111
- Sponsor's protocol ID
- 1-2013-0025
- Status last verified
- Dec 2016
- First submitted
- 9 Jul 2013
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34806762
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01918111
- Acronym / sponsor ID
- 1-2013-0025
- Conditions
- Resistant Hypertension
- Keywords
- Renal denervation, Exercise diastolic function, Atherosclerosis, New methods
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated early due to the difficulty of recruiting candidates.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 27 May 2016 (actual)
- Study completion
- 27 May 2016 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RD group | Experimental | Procedure: Renal denervationRenal denervation group |
| Control group | Active comparator | Drug: adenosine infusion treatmentControl group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervationRenal denervation will be performed via common femoral artery with standard endovascular technique and simplicity catheter | Procedure or surgery | RD group |
| adenosine infusion treatmentContinue hypertensive medication | Drug | Control group |
Primary outcome
Change in coronary atheroma
Time frame: 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
1 secondary outcome
Reduction of peak exercise E/E prime
Time frame: Peak exercise E/E prime from 6 and 12 months after renal denervation
Results and safety
The study was stopped early (reason given: The study terminated early due to the difficulty of recruiting candidates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 34806762Pisano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renal denervation and adenosine infusion treatment in people with Resistant Hypertension, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study terminated early due to the difficulty of recruiting candidates.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary atheroma (time frame: change in coronary atheroma for 24 months after renal denervation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.