Catheter-based renal denervation versus intensified medical
treatment in patients with resistant hypertension: Rationale
and design of a multicenter randomized study-PRAGUE-15

J 2014

Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15

TOUSEK, Petr, Jiri WIDIMSKY JR., Jan ROSA, Karol CURILA, Marian BRANNY et. al.

Basic information

Original name

Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15

Authors

TOUSEK, Petr (203 Czech Republic), Jiri WIDIMSKY JR. (203 Czech Republic), Jan ROSA (203 Czech Republic), Karol CURILA (203 Czech Republic), Marian BRANNY (203 Czech Republic), Igor NYKL (203 Czech Republic, guarantor, belonging to the institution), Milos TABORSKY (203 Czech Republic), Jan VACLAVIK (203 Czech Republic) and Petr WIDIMSKY (203 Czech Republic)

Edition

Cor et Vasa, Brno, Česká kardiologická společnost, 2014, 0010-8650

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

Czech Republic

Confidentiality degree

není předmětem státního či obchodního tajemství

RIV identification code

RIV/00216224:14110/14:00082093

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.crvasa.2014.04.004

UT WoS

000409978700004

Keywords in English

Adherence to treatment; Ambulatory blood pressure monitoring; Catheter-based renal denervation; Resistant hypertension; Spironolactone

Abstract

ORIG CZ

V originále

Catheter-based renal denervation (RDN) was considered as a promising method for treat-ment of resistant hypertension and was increasingly being used worldwide. However, there are equivocal results from only two randomized trials studying the effect of such interven-tion. Thus, additional data from properly designed long-term comparative trials are needed. The PRAGUE-15 trial is designed as an open, prospective, randomized multicenter trial comparing RDN versus intensified medical treatment in patients with resistant hyperten- sion. Patients randomized to the medical treatment group will receive spironolactone in the absence of contraindications. The primary endpoint will be changes in systolic and diastolic pressure during ambulatory blood pressure monitoring (ABPM) from baseline to 6 months. Herein, we describe the trial design and methodology. The strengths of the trial include ABPM (as the objective endpoint), independent outcomes assessment, and therapeutic use of spironolactone.

In Czech

Katetrová renální denervace(RDN)byla považována za nadějnou metodu pro léčbu rezistentní hypertenze a počet výkonů se celosvětově dále zvyšoval.Doposud byly publikovány s rozdílnými výsledky pouze dvě randomizované studie, které hodnotí efekt této intervence oproti medikamenózní léčbě.Proto jsou nutné další pečlivě designované srovnávací studie. Studie Prague -15 byla navržena jako otevřená randomizovaná prospektivní studie srovnávající účinek RDN s intenzifikovanou medikamentózní léčbou u pacientů s rezistentní hypertenzi. Pacienti randomizováni do medikamentózní větve budou užívat v léčbě spironolacton, pokud k tomu nebudou žádné kontraindikace.Primární cílový ukazatel studie byl stanoven jako změna hodnot systolického a diastolického tlaku během 24 hodinového ambulantního monitorování krevního tlaku (ABPM)mezi vstupní hodnotou a šestiměsíční kontrolou. V tomto článku popisujeme design a metodiku studie. Zásadní pro tuto studii je hodnocení změn krevního tlaku pomocí ABPM, nezávislé hodnocení a užívání spironolactonu v medikamentózní léčbě.

Citovat

TOUSEK, Petr, Jiri WIDIMSKY JR., Jan ROSA, Karol CURILA, Marian BRANNY, Igor NYKL, Milos TABORSKY, Jan VACLAVIK and Petr WIDIMSKY. Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15. Cor et Vasa. Brno: Česká kardiologická společnost, 2014, vol. 56, No 3, p. "e235"-"e239", 5 pp. ISSN 0010-8650. Available from: https://dx.doi.org/10.1016/j.crvasa.2014.04.004.

@article{1196553,
   author = {Tousek, Petr and Widimsky Jr., Jiri and Rosa, Jan and Curila, Karol and Branny, Marian and Nykl, Igor and Taborsky, Milos and Vaclavik, Jan and Widimsky, Petr},
   article_location = {Brno},
   article_number = {3},
   doi = {http://dx.doi.org/10.1016/j.crvasa.2014.04.004},
   keywords = {Adherence to treatment; Ambulatory blood pressure monitoring; Catheter-based renal denervation; Resistant hypertension; Spironolactone},
   language = {eng},
   issn = {0010-8650},
   journal = {Cor et Vasa},
   title = {Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15},
   volume = {56},
   year = {2014}
}

TY  - JOUR
ID  - 1196553
AU  - Tousek, Petr - Widimsky Jr., Jiri - Rosa, Jan - Curila, Karol - Branny, Marian - Nykl, Igor - Taborsky, Milos - Vaclavik, Jan - Widimsky, Petr
PY  - 2014
TI  - Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15
JF  - Cor et Vasa
VL  - 56
IS  - 3
SP  - "e235"-"e239"
EP  - "e235"-"e239"
PB  - Česká kardiologická společnost
SN  - 00108650
KW  - Adherence to treatment
KW  - Ambulatory blood pressure monitoring
KW  - Catheter-based renal denervation
KW  - Resistant hypertension
KW  - Spironolactone
N2  - Catheter-based renal denervation (RDN) was considered as a promising method for treat-ment of resistant hypertension and was increasingly being used worldwide. However, there are equivocal results from only two randomized trials studying the effect of such interven-tion. Thus, additional data from properly designed long-term comparative trials are needed. The PRAGUE-15 trial is designed as an open, prospective, randomized multicenter trial comparing RDN versus intensified medical treatment in patients with resistant hyperten- sion. Patients randomized to the medical treatment group will receive spironolactone in the absence of contraindications. The primary endpoint will be changes in systolic and diastolic pressure during ambulatory blood pressure monitoring (ABPM) from baseline to 6 months. Herein, we describe the trial design and methodology. The strengths of the trial include ABPM (as the objective endpoint), independent outcomes assessment, and therapeutic use of spironolactone.
ER  -

TOUSEK, Petr, Jiri WIDIMSKY JR., Jan ROSA, Karol CURILA, Marian BRANNY, Igor NYKL, Milos TABORSKY, Jan VACLAVIK and Petr WIDIMSKY. Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15. \textit{Cor et Vasa}. Brno: Česká kardiologická společnost, 2014, vol.~56, No~3, p.~''e235''-''e239'', 5 pp. ISSN~0010-8650. Available from: https://dx.doi.org/10.1016/j.crvasa.2014.04.004.

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