An interventional study of Renal sympathetic denervation in Uncontrolled Arterial Hypertension, sponsored by Heart Center Leipzig - University Hospital. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Heart Center Leipzig - University Hospital · Not applicable, Interventional, and Treatment
Among 282 studies in Hypertension with a site in Germany — 30 open to participants now, 46 under way, 11 of them phase 3. Hypertension · Germany.
Among the 282 studies in Hypertension with a site in Germany, this one is the 181st largest by planned enrollment of the 250 interventional ones that give a count, is one of 15 that started in 2025, is one of 67 with no phase, reaches primary completion later than 23 of the 45 other live ones, and was the 267th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →30 of the 282 studies in Hypertension with a site in Germany are open now.
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 29 · Phase 3 125 · Phase 4 26
First in 1998; this study’s year is marked. 15 started in 2025.
Median enrollment 200 across the 250 interventional studies, 120 across the 30 observational. Of the 219 that completed or were terminated, 81 (37%) have results posted.
200 of 282 have an industry lead sponsor. The 10 most frequent:
Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Heart Center Leipzig - University Hospital has 4 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
20 of the studies in Hypertension with a site in Germany that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT06948422Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) | 2027-09 |
| NCT06948435Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 | 2027-09 |
| NCT06952530Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2 | 2027-09 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
Among the 282 studies in Hypertension with a site in Germany, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Renal sympathetic denervation
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.
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)
Time frame: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Secondary endpoints
Time in target range months 7 to 9
Time frame: months 7 to 9
Secondary endpoints
Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation
Time frame: one week before renal denervation vs. 6 months after renal denervation
Secondary endpoints
Change in systemic sympathetic activity
Time frame: up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Feb 2027, 20 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 20 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Heart Center Leipzig - University Hospital