Clinical trial NCT01996033: EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Official title: This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncontrolled Hypertension
Keywords: uncontrolled hypertension
Renal Denervation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.

Brief summary: The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.

Detailed description: This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.

Eligibility criteria: Inclusion Criteria:

* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
* Subject is ≥18 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office Systolic Blood Pressure (SBP) ≥ 140 mmHg
* Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs

Exclusion Criteria:

* Subject has known significant renovascular abnormalities such as renal artery stenosis \> 30%
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has a history of hemodynamically significant valvular heart disease
* Subject has blood clotting abnormalities
* Subject life expectancy is \< 12 months, as determined by the Study Investigator
* Subject is participating in another clinical study which has the potential

Primary outcomes:
measure: Mean Reduction in Office Systolic Blood Pressure at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Reduction in Office Diastolic Blood Pressure
timeFrame: 6 Months
measure: Reduction in Office Diastolic Blood Pressure
timeFrame: 12 Months
measure: Reduction in Office Systolic Blood Pressure
timeFrame: 12 Months
measure: Reduction in 24 Hour Ambulatory Systolic Blood Pressure
timeFrame: 12 Months
measure: Reduction in 24 Hour Ambulatory Diastolic Blood Pressure
timeFrame: 12 Months
measure: Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
timeFrame: 1 Month
measure: Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
timeFrame: 6 Months
measure: Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
timeFrame: 12 Months
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 12 Months
Locations:
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
state: Baden-Wurttemberg
city: Immenstadt
country: Germany
facility: Kliniken Oberallgäu gGmbH Klinik Immenstadt
state: Bayern
city: Bernau
country: Germany
facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg
state: Brandenburg
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
state: Brandenburg
city: Schwalmstadt
country: Germany
facility: Asklepios Schwalm-Eder-Kliniken GmbH
state: Hesse
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH
state: Niedersachsen
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: Northrhine-Westphalia
city: Wuppertal
country: Germany
facility: Kardiologische Praxis Wuppertal
state: Northrhine-Westphalia
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
city: Düsseldorf
country: Germany
facility: Augusta-Krankenhaus Düsseldorf
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum Schwäbisch Hall gGmbH
Study officials:
affiliation: Elisabeth-Krankenhaus Essen, Germany
name: Christoph K Naber, MD
role: PRINCIPAL_INVESTIGATOR
References: