Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry

NCT02295683 | Terminated

• 1 other identifier: T124E2
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 2

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.

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (BP) Measurements

  Office BP; Ambulatory BP; Home BP

  Up to 5 year FU

Interventions

Renal Denervation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (2)

Clinical Center of Serbia

Belgrade, Serbia

Location

Hospital Galdakao

Galdakao, Spain

Location

Study Officials

• José Ramon Rumoroso, Dr.

  Hospital Galdakao

  PRINCIPAL INVESTIGATOR

• Palop López, Dr.

  Hospital San Juan Alicante

  PRINCIPAL INVESTIGATOR

• Mauri, Dr.

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Perez, Dr.

  Hospital de Léon

  PRINCIPAL INVESTIGATOR

• Garcia, Dr.

  Hospital Monteprincipe

  PRINCIPAL INVESTIGATOR

• Goicolea, Dr.

  Hospital Puerta de Hierro

  PRINCIPAL INVESTIGATOR

• Goran Stankovic, Dr.

  Clinical Center of Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 30, 2016
• Study Completion: September 4, 2017
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

SE (1); ES (1)