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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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12 December 2020 |
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Main ID: |
NCT02295683 |
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Date of registration:
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17/11/2014 |
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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 by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
Iberis |
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Scientific title:
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Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02295683 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Serbia
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Spain
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Contacts
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Name:
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Goicolea, 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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Hospital Puerta de Hierro |
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Name:
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Goran Stankovic, 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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Clinical Center of Serbia |
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Name:
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José Ramon Rumoroso, 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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Hospital Galdakao |
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Name:
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Garcia, 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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Hospital Monteprincipe |
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Name:
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Mauri, 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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Germans Trias i Pujol Hospital |
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Name:
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Perez, 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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Hospital de Léon |
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Name:
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Palop López, 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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Hospital San Juan Alicante |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =18 years or minimum age as required by local regulations.
- Patient has been thoroughly informed about this registry and signed Informed Consent
Form.
- Patient with true resistant hypertension defined as:
- Office systolic BP higher than 160 or 150mmHg in case of type 2 diabetes
- Ambulatory BP with average BP>130mmHg or mean daytime>135mmHg in more than 70% of
the measurements.
- Patients should be on stable hypertension therapy for at least 8 weeks before
procedure, including spironolactone if they are supposed to be respondent as indicated
by the specialized center/excellence unit on hypertension.
Exclusion Criteria:
- Previous renal artery intervention (balloon angioplasty or stenting).
- Evidence of renal artery atherosclerosis (defined as a renal artery stenosis >50%).
- Main renal arteries of less than 4mm diameter or less than 20mm in length.
- Presence of multiple main renal arteries in either kidney.
- Estimated glomerular filtration rate <45ml/min per 1,73m2
- Recent myocardial infarction, unstable angina pectoris or cerebrovascular accident
within the past 3-6 months.
- False resistant hypertension (pseudo resistance) by using 24h ambulatory BP monitoring
(ABPM).
- Secondary arterial hypertension.
- Pregnancy.
- There is another pathological process with well-known life expectancy of less than 5
years.
- Patient unable to do correct FU.
- Unable to take correct ambulatory BP.
- Primary hyperaldosteronism.
- Known lack of adherence to medical treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Resistant Hypertension
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Intervention(s)
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Device: Renal Denervation
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Primary Outcome(s)
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Blood Pressure (BP) Measurements
[Time Frame: Up to 5 year FU]
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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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