Clinical trial NCT02295683: Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
Official title: Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Resistant Hypertension
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uncontrolled hypertension entitled to receive renal sympathetic denervation treatment per routine hospital practice and according to relevant international, or country specific guidelines

Brief summary: 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.

Detailed description: This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.

This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.

A minimum of 30 patients will be enrolled in Europe

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure (BP) Measurements
timeFrame: Up to 5 year FU
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Galdakao
country: Spain
facility: Hospital Galdakao
Study officials:
affiliation: Hospital Galdakao
name: José Ramon Rumoroso, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Juan Alicante
name: Palop López, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Mauri, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Léon
name: Perez, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Monteprincipe
name: Garcia, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro
name: Goicolea, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Center of Serbia
name: Goran Stankovic, Dr.
role: PRINCIPAL_INVESTIGATOR
References: