Therapy Resistant Arterial HypertensionEFFECTIVENESNCT02772939
Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
A study testing Renal sympathetic denervation (RDN) in people with Therapy Resistant Arterial Hypertension, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Therapy Resistant Arterial Hypertension
- What is being tested?
- Renal sympathetic denervation (RDN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to May 2022
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with therapy resistant arterial hypertension (>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP >160 mmHg systolic or 90 mmHg diastolic
Who cannot join
- average systolic daytime BP <135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
- pregnancy
- known renal artery stenosis
- >= 1 renal artery diameter < 4 mm
- life expectancy <6 months
- participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
Read the detailed description
Regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. Previous data shows, that to some extent this might be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. This trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.
- Conditions
- Therapy Resistant Arterial Hypertension
- Being tested
- Renal sympathetic denervation (RDN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervation (RDN)Device
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal denervation for therapy resistant arterial hypertension Receives: Device: Renal sympathetic denervation (RDN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
difference in daytime blood pressure (ABPM) between patients with low (<14.4 m/s) vs. high invasive pulse wave velocity
Measured: 3 Months
Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity assessed invasively, with a piezoelectric device and MRI-based) in combination with clinical variables
AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation
Measured: 3 Months
Secondary outcomes (7)
Change in 24h ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Change in exercise blood pressure
Measured: 3 months
Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
comparison of predictive value of invasive pulse wave velocity, invasive central pulse pressure, noninvasive pulse wave velocity, noninvasive central pulse pressure, aortic distensibility, total arterial compliance for Change in ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2020
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy Resistant Arterial HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772939
- Sponsor's protocol ID
- Effectiveness0001
- Acronym
- EFFECTIVENES
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2016
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
- ClinicalTrials.gov ID
- NCT02772939
- Acronym / sponsor ID
- EFFECTIVENES / Effectiveness0001
- Conditions
- Therapy Resistant Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 16 May 2016 (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.
This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
Detailed description
Regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. Previous data shows, that to some extent this might be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. This trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal sympathetic denervation (RDN)Renal denervation for therapy resistant arterial hypertension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with therapy resistant arterial hypertension (>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP >160 mmHg systolic or 90 mmHg diastolic
Key exclusion criteria (6 listed)
- average systolic daytime BP <135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
- pregnancy
- known renal artery stenosis
- >= 1 renal artery diameter < 4 mm
- life expectancy <6 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 sympathetic denervation (RDN)Catheter based renal sympathetic denervation for therapy resistant arterial hypertension | Device | Renal Denervation |
Primary outcome
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
Time frame: 3 Months
difference in daytime blood pressure (ABPM) between patients with low (<14.4 m/s) vs. high invasive pulse wave velocity
Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity assessed invasively, with a piezoelectric device and MRI-based) in combination with clinical variables
Time frame: 3 Months
AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation
7 secondary outcomes
Change in 24h ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Change in exercise blood pressure
Time frame: 3 months
Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
comparison of predictive value of invasive pulse wave velocity, invasive central pulse pressure, noninvasive pulse wave velocity, noninvasive central pulse pressure, aortic distensibility, total arterial compliance for Change in ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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 study testing Renal sympathetic denervation (RDN) in people with Therapy Resistant Arterial Hypertension, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 10 Aug 2022. 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 Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022.