Trial document





This trial has been registered retrospectively.
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  DRKS00010221

Trial Description

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Title

Pausing the barostimulation to test its efficacy in therapy resistant hypertension

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With this project we aim to further prove the efficacy of the barostimulation therapy in therapy resistent hypertension. Barostimulation is a device-based therapie, where a pacemaker like device triggers a reflex which reduces blood pressure. This therapy is approved for patients with blood pressure above 140/90 mmHg in spite of ongoing therapy with at least 3 antihypertensive drugs. At the University Clinic of Cologne we already treat 35 patientes with therapy resistant hypertension with this device. In this project we plan to pause the barostimulation therapy for 4 weeks before operative device replacement (because of a low battery Status) in a crossover design.
With this we aim to gain knowledge about the individual and general therapy response and efficacy of the barostimulation therapy. If we cannot prove its efficacy in an individual patient the device will not be replaced but explanted if that is the patient's wish.
We hypothesize that we can prove that barostimulation is an effective therapy in resistant Hypertension.

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Brief Summary in Scientific Language

With this project we aim to further prove the efficacy of the barostimulation therapy in therapy resistent hypertension. Barostimulation is a device-based therapie which activates the baroreflex via electrical stimulation of the carotid sinus. An electrical pulse generator is implanted below the clavicle and one small electrode ist connected to the artery wall near the carotid sinus. This therapy is approved for patients with blood pressure above 140/90 mmHg in spite of ongoing therapy with at least 3 antihypertensive drugs. At the University Clinic of Cologne we already treat 35 patientes with therapy resistant hypertension with this device. In this project we plan to pause the barostimulation therapy for 4 weeks before operative device replacement because of a low battery status. With this we aim to gain knowledge about the individual and general therapy response and efficacy of the barostimulation therapy. If we cannot prove its efficacy in an individual patient the device will not be replaced but explanted if that is the patient's wish.

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Organizational Data

  •   DRKS00010221
  •   2017/07/18
  •   [---]*
  •   yes
  •   Approved
  •   16-132, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Therapy resistant hypertension
  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   Pausing the barostimulation therapy for the first 4 weeks of the trial, continuing the barostimulation therapy for the second 4 weeks of the trial
  •   Continuing the barostimulation therapy in the first 4 weeks of the trial, pausing the barostimulation therapy for the second 4 weeks of the trial
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

relevant rise of blood pressure after 1 month pause of barostimulation therapy measured in telemetric and/or office blood pressure

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/06
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- therapy resistant hypertension where secondary causes of hypertension have been excluded
- barostimulation with low battery Status
- written consent to participate in the trial after the patient has been informed of the content of the trial in writing and in person

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Exclusion Criteria

- battery replacement of the barostimulation device not possible at the moment because of medical or other reasons
- therapeutic effect of the barostimulation therapy has already been proven in this patient

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Addresses

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    • Universitätsklinik Köln Kardiologie
    • Mr.  PD Dr. med  Marcel  Halbach 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinik Köln Kardiologie
    • Ms.  Dr. med  Lisa  Ulbrich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Universitätsklinik Köln Kardiologie
    • Ms.  Dr. med  Lisa  Ulbrich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.