NCT02029885

Brief Summary

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable hypertension

Geographic Reach
7 countries

27 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

January 6, 2014

Last Update Submit

January 6, 2016

Conditions

Hypertension

Keywords

HypertensionRenal Denervation

Outcome Measures

Primary Outcomes (2)

  • Safety at 6 weeks follow-up

    Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 6-weeks follow-up. * All cause mortality; * End-stage Renal Disease defined as eGFR \< 15 ml/min or need for renal replacement therapy * Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications as assessed by toxicological and other medical analyses and testing. OR \- New renal artery stenosis \> 70% confirmed by angiography within 6 months of randomization

    6 weeks

  • Change in OBP

    Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.

    6 months

Secondary Outcomes (1)

  • Change in ABPM

    6 months

Other Outcomes (6)

  • Chronic Safety

    6 months

  • Reduction in blood pressure

    6 months

  • Incidence of achieving target OBP

    6 months

  • +3 more other outcomes

Study Arms (2)

Investigational Therapy (Surround Sound)

EXPERIMENTAL

Investigational Therapy using external focused ultrasound

Device: Investigational Therapy (Surround Sound)

Sham Control

SHAM COMPARATOR

Blinded Sham Control Arm

Device: Sham Control

Interventions

Investigational Therapy (Surround Sound)DEVICE
Investigational Therapy (Surround Sound)
Sham ControlDEVICE
Sham Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is at least 18 years of age and no more than 90 years of age
  • Average SBP ≥ 160 mmHg
  • hour average ABPM daytime SBP ≥ 135 mmHg.
  • No medication changes for a minimum of 1 months prior to screening.
  • At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
  • Highest labeled dose according to medication's labeling;
  • Highest usual dose per clinical guidelines JNC-7;
  • Highest tolerated dose; and/or
  • Highest appropriate dose for the subject per the PI's clinical judgment.
  • Subject has two functioning kidneys.
  • Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).

You may not qualify if:

  • Subject has any secondary cause of hypertension
  • Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
  • Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
  • Subject has a history of intra-abdominal surgery within the past six months
  • Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
  • Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
  • MI, unstable angina, or CVA in the prior 6 months.
  • Known severe primary pulmonary HTN
  • Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
  • Subject has hemodynamically significant valvular heart disease.
  • Subject has BMI over 40 km/m\^2
  • Subject has a target treatment depth over 13 cm.
  • Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
  • Subject is pregnant, nursing, or intends to become pregnant during the trial period.
  • Subject is currently enrolled in other potentially confounding research.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Monash Medical Centre

Clayton, Australia

TERMINATED

Medizinischen Universität Wien -UK für Klinische Pharmakologie

Vienna, Austria

RECRUITING

Angiografia de Occidente, S.A.

Cali, Colombia

TERMINATED

CHD Cardio Centro de Excelencia SAS

Cali, Colombia

TERMINATED

St. Anne's University Hospital

Brno, Czechia

ACTIVE NOT RECRUITING

University Hospital Brno

Brno, Czechia

ACTIVE NOT RECRUITING

Městská Nomocnice Ostrava

Ostrava, Czechia

ACTIVE NOT RECRUITING

General University Hospital

Prague, Czechia

WITHDRAWN

Nemocnice Na Homolee Hospital

Prague, Czechia

ACTIVE NOT RECRUITING

University Hospital Bonn

Bonn, Germany

RECRUITING

Uniklinik Köln

Cologne, Germany

RECRUITING

University Hospital of the University of Erlangen-Nuremberg

Erlangen, Germany

RECRUITING

CardioVascular Center Frankfurt - Sankt Katharinen Hospital

Frankfurt, Germany

RECRUITING

University Hospital Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Universitaetsklinikum Leipzig

Leipzig, Germany

RECRUITING

Sana CardioMed Nord

Lübeck, Germany

RECRUITING

Deutsches Herzzentrum Muenchen

Munich, Germany

RECRUITING

Clemens Hospital GmbH

Münster, Germany

RECRUITING

Mercy Angiography

Aukland, New Zealand

ACTIVE NOT RECRUITING

Oddział Kliniczny II Kliniki Kardiologii

Krakow, Poland

RECRUITING

Institute Of Cardiology

Warsaw, Poland

RECRUITING

Birmingham Heartlands Hospital

Birmingham, United Kingdom

RECRUITING

University Hospital Wales

Cardiff, United Kingdom

RECRUITING

Royal Devon and Exeter Hospital

Exeter, United Kingdom

RECRUITING

University of Glasgow

Glasgow, United Kingdom

RECRUITING

St. Bartholomew's Hospital

London, United Kingdom

RECRUITING

University College London

London, United Kingdom

WITHDRAWN

Southampton University Hospital

Southampton, United Kingdom

RECRUITING

Related Publications (1)

  • Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12):e009151. doi: 10.1161/JAHA.118.009151.

    PMID: 29895590DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Therapies, Investigational

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Roland Schmieder, MD

    University Hospital of University of Erlangen-Nuremberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Dawood

CONTACT

odawood@konamedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2018

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

CO(2)AU(1)DE(9)NZ(1)PL(2)GB(7)CZ(5)