Uncontrolled Arterial HypertensionPREDICT-RDNNCT06845579
Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
A study testing Renal sympathetic denervation in people with Uncontrolled Arterial Hypertension, run by Heart Center Leipzig - University Hospital at 2 sites in Germany.
Trial summary
Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Arterial Hypertension
- What is being tested?
- Renal sympathetic denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2025to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
- Treatment with 3 to ≤5 antihypertensive drug classes
- Age >18 years
- Written informed consent
Who cannot join
- Age ≤ 18 years
- anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
- pregnancy
- patients under legal supervision or guardianship
- participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Heart Center Leipzig
Leipzig, Saxony, 04289
Karl Fengler, Dr. med., +49341865251197, Karl.Fengler@helios-gesundheit.de
Karl Fengler, Dr. med.
- Not yet recruiting
Universitätsmedizin Mainz Kardiologie I
Mainz, Rheinland Pflanz, 55131
Philipp Lurz, Prof. Dr. med.
Philipp Lurz, Prof. Dr. med.
About this study
Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
- Conditions
- Uncontrolled Arterial Hypertension
- Being tested
- Renal sympathetic denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationProcedure or surgery
All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Other | All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist. Receives: Procedure: Renal sympathetic denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Measured: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Secondary outcomes (3)
Secondary endpoints
Time in target range months 7 to 9
Measured: months 7 to 9
Secondary endpoints
Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation
Measured: one week before renal denervation vs. 6 months after renal denervation
Secondary endpoints
Change in systemic sympathetic activity
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helios Health Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Karl Fengler, Dr. med., Principal investigator, Heart Center Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845579
- Sponsor's protocol ID
- 2024-0108
- Acronym
- PREDICT-RDN
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
- ClinicalTrials.gov ID
- NCT06845579
- Acronym / sponsor ID
- PREDICT-RDN / 2024-0108
- Conditions
- Uncontrolled Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Collaborators
- Helios Health Institute GmbH
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 25 Feb 2025 (actual)
- 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.
Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Other | Procedure: Renal sympathetic denervationAll procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
- Treatment with 3 to ≤5 antihypertensive drug classes
- Age >18 years
- Written informed consent
Key exclusion criteria (5 listed)
- Age ≤ 18 years
- anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
- pregnancy
- patients under legal supervision or guardianship
- participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
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 denervationAll procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist. | Procedure or surgery | Renal sympathetic denervation |
Primary outcome
Primary endpoint
Time frame: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
3 secondary outcomes
Secondary endpoints
Time frame: months 7 to 9
Secondary endpoints
Time frame: one week before renal denervation vs. 6 months after renal denervation
Secondary endpoints
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
Karl Fengler, Dr. med. principal investigator
Heart Center Leipzig
2 sites 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 in people with Uncontrolled Arterial Hypertension, run by Heart Center Leipzig - University Hospital at 2 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)). 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 24 Jun 2025.