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Chemical renal denervation for the treatment of resistant hypertension

Organizational Data

DRKS-ID:
DRKS00008746
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2019-06-19
Last update in DRKS:
2023-09-19
Registration type:
Prospective

Acronym/abbreviation of the study

CRASH

URL of the study

No Entry

Brief summary in lay language

Decrease of average systolic ambulatory blood pressure after CT-guided ethanol renal denervation compared to a control group with sham intervention. Both study groups receive a standardized antihypertensive medication 4 weeks prior to inclusion in the study. No change in the standardized anti-hypertensive medication is allowed during the study, medication optimization within the framework of standard treatment is allowed during the duration of the study. Planned study duration is 6 months.

Brief summary in scientific language

Decrease of the mean systolic ABP after CT-guided ethanol RSD compared to a control group undergoing sham procedure 6 months after intervention. Both arms receive standardized antihypertensive medication for 4 weeks before randomization. No change of standard medication other than dose adjustment for 6 months.

Health condition or problem studied

ICD10:
I10.9
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Therapy Arm: 24-hour blood pressure measurements and automated office-blood-pressure (RR) measurements are taken before the intervention (baseline). After patient approval, therapy is performed by image-guided instillation of a neurolytic near the renal arteries. Follow-up with duplex sonography, MRI incl. MR angiography or detection of further complications are recorded in the high-pressure nephrology or Department of radiology Immediately after the intervention and after 3, 6, 12, 18 and 24 months, the blood pressure is measured.
Arm 2:
SHAM Arm: 24-hour blood pressure measurements and automated office-blood-pressure (RR) measurements are taken before the intervention (baseline). After patient consent, therapy is performed by Sham therapy near the renal arteries. Follow-up with duplex sonography, MRI incl. MR angiography or detection of further complications are recorded in the high-pressure nephrology or Department of radiology Immediately after the intervention and after 3, 6, 12, 18 and 24 months, the blood pressure is measured.

Endpoints

Primary outcome:
The procedure leads to a permanent lowering of blood pressure compared to the control group (state of the art antihypertensive medication plus sham treatment).
Secondary outcome:
• Permanent reduction of antihypertensive medication in patients with refractory hypertension compared to sham control • Compared to catheter-guided radiofrequency ablation, the procedure is simpler, faster, less expensive, and feasible for patients with a contraindication to RFA.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Caregiver
  • Data analyst
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik und Poliklinik für Radiologie München

Recruitment period and number of participants

Planned study start date:
2019-06-28
Actual study start date:
2019-06-28
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
100
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
75 Years
Additional Inclusion Criteria:
• Patient with therapy-resistant type. Hypertonicity (syst. RR> 140 mmHg despite optimized therapy with ≥ 3 antihypertensive drugs of different classes - state of the art over 3 months), • Diagnosis of the therapy-resistant type. Hypertension by a specialist in nephrology / high-pressure ambulance takes place incl. Advice on all alternative therapy methods • GFR> 45 ml / min / 1.73 m² Pat. With refractory hypertension at Z.n. ineffective catheter-directed RDN

Exclusion Criteria

• patients with secondary hypertension (e.g., renoparenchymatous hypertension, NAST, primary hyperaldosteronism, pheochromocytoma, sleep apnea syndrome) • Stenosing heart valve disease • Z.n. Myocardial infarction, unstable angina pectoris, cerebrovascular event within the last 6 months prior to enrollment

Addresses

Primary Sponsor

Klinikum der Universität München, Campus Großhadern
Marchioninistraße 15
81377 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Prof. Jens Ricke
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-4400 72750
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html

Contact for Public Queries

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Christel Besseler
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-73647
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://intranet.klinikum.uni-muenchen.de

Principal Investigator

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Prof. Jens Ricke
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-4400 72750
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html

Other contact for scientific queries

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Dr. Daniel Puhr-Westerheide
Marchioninistr. 15
81377 München
Germany
Telephone:
+49 89 440073660
Fax:
+49 89 440076648
Contact per E-Mail
URL:
http://intranet.klinikum.uni-muenchen.de

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinikum der Universität München, Campus Großhadern
Marchioninistraße 15
81377 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-07-20
Ethics committee number:
18-599
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-02-22

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
LMU-RAD00009 - interne Studien-ID LMU Radiologie
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry