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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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7 November 2016 |
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Main ID: |
NCT01656096 |
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Date of registration:
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31/07/2012 |
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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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Renal Sympathetic Denervation in Mild Refractory Hypertension
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Scientific title:
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Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01656096 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Steffen Desch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heartcenter Leipzig GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Refractory hypertension: 3 or more antihypertensive agents of different classes
(including a diuretic) at optimal dosage without change in the 4 weeks preceding
randomization
- Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg
(ABPM mean daytime values)
- No change in blood pressure medication within 6 months after randomization
- Age 18 to 75 years
- Informed consent
Exclusion Criteria:
- Blood pressure outside range mentioned above
- Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
- Estimated glomerular filtration rate <45 mL/min/1.73 m² (modification of diet in
renal disease formula)
- Unstable angina pectoris
- Myocardial infarction within 6 months prior to randomization
- Planned surgery or cardiovascular intervention within 6 months after randomization
- Severe heart valve disease
- Severe comorbidities with limited life expectancy
- Pregnancy
- Participation in another trial
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Refractory Hypertension
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Intervention(s)
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Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
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Other: Sham procedure
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Primary Outcome(s)
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Change in systolic blood pressure (ABPM mean value)
[Time Frame: 6 months]
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Secondary ID(s)
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RSD-Leipzig
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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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