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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT02519868 |
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Date of registration:
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07/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chemical Block and Electrical Stimulation of the Carotid Body to Treat Refractory Hypertension
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Scientific title:
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Chemical Block and Electrical Stimulation of the Carotid Body to Treat Refractory Hypertension |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02519868 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Eric Albrecht, PD Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHUV |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-70 years of age, inclusive;
- blood pressure not controlled despite 3 different anti-hypertensive drugs;
- minimal body weight of 70 kg.
Exclusion Criteria:
- history of neck surgery or radiotherapy;
- secondary hypertension;
- contraindications to regional anesthesia (e.g., allergy to local anesthetics,
coagulopathy, bleeding diathesis, malignancy or infection in the area);
- pregnancy;
- severe respiratory disease;
- inability to understand the informed consent and demands of the study;
- patient refusal.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Device: Electrical block
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Device: Chemical block
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Primary Outcome(s)
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Blood pressure
[Time Frame: 15 minutes after electrical block and 15 minutes after chemical block]
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Secondary Outcome(s)
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Presence of dyspnea
[Time Frame: During the procedure]
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Presence of hoarseness
[Time Frame: During the procedure]
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Heart rate
[Time Frame: 15 minutes after each intervention]
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Presence of paraesthesia
[Time Frame: During the procedure]
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Presence of hematoma
[Time Frame: During the procedure]
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Presence of Claude-Bernard-Horner Syndrome
[Time Frame: During the procedure]
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Secondary ID(s)
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CER 227-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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