Resistant Hypertension Clinical Trial
— IberisOfficial title:
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry
NCT number | NCT02295683 |
Other study ID # | T124E2 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | September 4, 2017 |
Verified date | October 2019 |
Source | Terumo Europe N.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
Status | Terminated |
Enrollment | 18 |
Est. completion date | September 4, 2017 |
Est. primary completion date | November 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical Center of Serbia | Belgrade | |
Spain | Hospital Galdakao | Galdakao |
Lead Sponsor | Collaborator |
---|---|
Terumo Europe N.V. |
Serbia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure (BP) Measurements | Office BP; Ambulatory BP; Home BP | Up to 5 year FU |
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