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

Toušek, Petr; Widimský, Jiří; Rosa, Ján; Čurila, Karol; Branny, Marian; Nykl, Igor; Táborský, Miloš; Václavík, J.; Widimský, Petr

doi:10.1016/j.crvasa.2014.04.004

Cited by 9 publications

(6 citation statements)

References 27 publications

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“…The exact study design ( Figure S1 in the online-only Data Supplement) and power and sample-size analysis has been previously reported. 7 Only patients with RH were included (with an office systolic BP >140 mm Hg after treatment with ≥3 antihypertensive drugs at optimal doses, including a diuretic). Secondary causes of hypertension (eg, primary aldosteronism, pheochromocytoma, Cushing syndrome, renal parenchymal disease, renovascular hypertension, drug-induced hypertension, or other conditions) were excluded in all subjects before randomization.…”

Section: Methodsmentioning

confidence: 99%

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

et al. 2015

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T he prevalence of patients with resistant hypertension (RH) varies from 5% to 30%.1 Identification of true-RH, when secondary causes and medication noncompliance are excluded, is becoming more important with the implementation of novel, nondrug therapeutic approaches to RH, such as catheter-based renal-artery denervation (RDN) or baroreflex stimulation. Pilot studies using RDN described the method as feasible, effective, and safe for reducing blood pressure (BP) in the short term. 2-4The interpretation of the results from the majority of these studies was complicated by the lack of 24-hour ambulatory blood pressure monitoring (24-hour ABPM) data, lack of compliance confirmation, or small follow-up sample sizes.This study seeks to evaluate the efficacy of RDN in a prospective multicenter randomized trial with the acronym PRAGUE-15 in patients with true-RH, according to the recommendations for RDN.5 Twenty-four-hour ABPM, exclusion of secondary hypertension and evaluation of treatment compliance served as confirmation of true resistance. The efficacy of RDN was compared with intensified antihypertensive treatment including the use of spironolactone. To date, only 1 study has compared RDN with intensified pharmacological treatment.6 However, only 19Abstract-This prospective, randomized, open-label multicenter trial evaluated the efficacy of catheter-based renal denervation (Symplicity, Medtronic) versus intensified pharmacological treatment including spironolactone (if tolerated) in patients with true-resistant hypertension. This was confirmed by 24-hour ambulatory blood pressure monitoring after excluding secondary hypertension and confirmation of adherence to therapy by measurement of plasma antihypertensive drug levels before enrollment. One-hundred six patients were randomized to renal denervation (n=52), or intensified pharmacological treatment (n=54) with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. A significant reduction in 24-hour average systolic blood pressure after 6 months (−8. Betweengroup differences in change were not significant. The average number of antihypertensive drugs used after 6 months was significantly higher in the pharmacological group (+0.3 drugs; P<0.001). A significant increase in serum creatinine and a parallel decrease of creatinine clearance were observed in the pharmacological group; between-group difference were borderline significant. The 6-month results of this study confirmed the safety of renal denervation. In conclusion, renal denervation achieved reduction of blood pressure comparable with intensified pharmacotherapy.

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Section: Methodsmentioning

confidence: 99%

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

et al. 2015

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“…In another randomised trial PRAGUE-15, it was demonstrated that the RDN is not as successful in reducing BP values as adding spironolactone [11]. This prospective, randomised, open, and multi-centre study investigated the effectiveness of the RDN procedure compared to the intensification of the pharmacological treatment using spironolactone (if it was tolerated) in patients with truly resistant AH.…”

Section: Inconclusive Results and Post-simplicity-3 Disappointmentmentioning

confidence: 99%

Denervation of the renal arteries — what next?

2017

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and Coordinator of the study "RDN-Pol Registry" in Poznan. Her scientific research interests include resistant hypertension, renal denervation, hyperuricaemia in hypertension, central blood pressure, and chronotherapy of hypertension. She is a member of European Society of Hypertension, European Society of Cardiology, American Society of Hypertension, and 'Club 30' of the Polish Cardiac Society. She is the co-author of 2015 Guidelines for the Management of Hypertension Recommendations of the Polish Society of Hypertension.

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“…Většina hodnocených pacientů byla randomizována ve studii PRAGUE-15, dva pacienti se zúčastnili pilotní fáze projektu, podstoupili denervaci před zahájením studie, ale splňovali stejná vstupní kritéria skutečně rezistentní hypertenze jako účastnící studie a byli sledováni ve stejném rozsahu jako randomizovaní pacienti. 6,[28][29][30] Všichni pacienti podepsali informovaný souhlas. Studie byla schválena multicentrickou etickou komisí a všemi třemi místními institucionálními etickými komisemi.…”

Section: Soubor a Metodikaunclassified

(Prediction of long-term renal denervation efficacy)

Kvasnička¹,

Lambert²,

Waldauf³

et al. 2019

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Diverzita odpovědi krevního tlaku na renální denervaci a velká variabilita mezi studiemi podtrhují význam potřeby identifi kace prediktorů účinnosti renální denervace. Předchozí studie identifi kovaly řadu prediktorů pro tří-až šestiměsíční období. Cílem této studie bylo zjistit možné prediktory trvalého poklesu krevního tlaku (TK) po renální denervaci v dlouhodobém horizontu dvou let. Hodnocení pacienti byli buď randomizováni ve studii PRAGUE-15, nebo se zúčastnili pilotní fáze projektu a splňovali stejná vstupní kritéria skutečně rezistentní hypertenze. Za účinnou odpověď byl považován pokles 24h systolického TK o ≥ 10 mm Hg během 6, 12 a 24 měsíců po výkonu. Navíc byly analyzovány i jednotlivé návstěvy. Denervace byla provedena za použití unipolárního systému pro renální denervaci Symplicity. Dále byla provedena detailní analýza CT angiografi e renálních tepen včetně hodnocení morfologie renálních tepen. Celkem bylo analyzováno 48 pacientů, z toho pro účely dlouhodobé predikce bylo vhodných 27 z nich. Pět z 27 pacientů bylo označeno jako dlouhodobí respondéři s průměrným poklesem 24h TK o 20/9 mm Hg. Nejvýznamnějšími prediktory poklesu TK byly vyšší úvodní 24h systolický TK (p = 0,01) a větší průměr levé renální tepny (p = 0,04). Přetrvávající pokles TK byl zaznamenán jen u menšiny pacientů po renální denervaci. Jako nejlepší prediktory pro přetrvávající pokles TK jsme identifi kovali vyšší úvodní TK a větší průměr renální tepny. Právě průměr renální tepny by mohl usnadnit provedení ablace v periferii a naše výsledky mohou teoreticky podporovat aktuální hypotézu o potřebě ablovat distální části renální arterie.

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

Cited by 9 publications

References 27 publications

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

Denervation of the renal arteries — what next?

(Prediction of long-term renal denervation efficacy)

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