Trial document




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  DRKS00008746

Trial Description

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Title

Chemical renal denervation for the treatment of resistant hypertension

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Trial Acronym

CRASH

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URL of the Trial

[---]*

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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.

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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.

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Organizational Data

  •   DRKS00008746
  •   2019/06/19
  •   [---]*
  •   yes
  •   Approved
  •   18-599, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   LMU-RAD00009  (interne Studien-ID LMU Radiologie)
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Health Condition or Problem studied

  •   I10.9 -  [generalization I10: Essential (primary) hypertension]
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Interventions/Observational Groups

  •   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.
  •   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.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   No
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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).

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/28
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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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

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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

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Medizinische Klinik und Poliklinik IVKlinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Michael  Fischereder 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Florian  Streitparth 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Dr.  Daniel  Puhr-Westerheide 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Ms.  Christel  Besseler 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.