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LH12054

A Feasibility Study: A safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients with Refractory Hypertension

Public support

  • Provider

    Ministry of Education, Youth and Sports

  • Programme

    KONTAKT II

  • Call for proposals

    KONTAKT II 2 (SMSM2012LH2)

  • Main participants

    Nemocnice Na Homolce

  • Contest type

    VS - Public tender

  • Contract ID

    MSMT-6805/2013-311

Alternative language

  • Project name in Czech

    Ověřovací studie k ověření účinnosti aplikace vysoce fokusovaného ultrazvuku (HIFU) k provedení extrakorporální denervace renálního sympatiku u nemocných s rezistentní arteriální hypertenzí

  • Annotation in Czech

    Primárním cílem projektu je ověřit bezpečnost provedení denervace renálního sympatiku aplikací vysoce fokusovaného ultrazvuku u nemocných s rezistentní hypertenzí. Sekundárním cílem je ověření účinnosti denervace renálního sympatiku s pravidelným monitorováním arteriální hypertenze u léčených pacientů. Tato studie by měla trvat 45 měsíců včetně dokončení sledování nemocných.

Scientific branches

  • R&D category

    AP - Applied research

  • CEP classification - main branch

    FA - Cardiovascular diseases including cardio-surgery

  • CEP - secondary branch

    ED - Physiology

  • CEP - another secondary branch

    FB - Endocrinology, diabetology, metabolism, nutrition

  • OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)

    30105 - Physiology (including cytology)<br>30201 - Cardiac and Cardiovascular systems<br>30202 - Endocrinology and metabolism (including diabetes, hormones)

Completed project evaluation

  • Provider evaluation

    V - Vynikající výsledky projektu (s mezinárodním významem atd.)

  • Project results evaluation

    Wave study is focused on ultrasound energy applied for renal denervation in patients with resistent arterial hypertension.We evaluated US energy application in several fashions in total 72 patients. In several Wave substudies we use focused US energy during development of extracorporeal application of renal denervation, which should covered the most of the sympathetic nerves around the renal artery and also minimized or completely minimized damage of renal artery. In the initial phase we were focused on the application of the ultrasound from intravascular space. We included 20 patients, and 1 month after therapy systolic blood pressure dropped down by 21.2 mmHg and diastolic BP by 8.3 mmHg and 3 months after systolic BP by 23,5 mmHg and diastolic by 10,6 mmHg! For extracorporeal application of US we included 45 patients, average of age Ø 59 years, (7 m/8w), with systolic BP > 160 mmHg. Within this patient group we observed lowering of the BP after 1 month Ø 16/6 mmHg

Solution timeline

  • Realization period - beginning

    Mar 1, 2012

  • Realization period - end

    Dec 31, 2015

  • Project status

    U - Finished project

  • Latest support payment

    Feb 27, 2015

Data delivery to CEP

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

  • Data delivery code

    CEP16-MSM-LH-U/01:1

  • Data delivery date

    Oct 9, 2017

Finance

  • Total approved costs

    4,578 thou. CZK

  • Public financial support

    3,558 thou. CZK

  • Other public sources

    0 thou. CZK

  • Non public and foreign sources

    1,020 thou. CZK