title: Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study.
abstract: 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 (-8.6 [95% cofidence interval: -11.8, -5.3] mm Hg; P<0.001 in renal denervation versus -8.1 [95% cofidence interval: -12.7, -3.4] mm Hg; P=0.001 in pharmacological group) was observed, which was comparable in both groups. Similarly, a significant reduction in systolic office blood pressure (-12.4 [95% cofidence interval: -17.0, -7.8] mm Hg; P<0.001 in renal denervation versus -14.3 [95% cofidence interval: -19.7, -8.9] mm Hg; P<0.001 in pharmacological group) was present. Between-group 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.
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.). jan.rosa@lf1.cuni.cz.
authors.forename: Ján
authors.initials: J
authors.lastname: Rosa
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Petr
authors.initials: P
authors.lastname: Widimský
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Petr
authors.initials: P
authors.lastname: Toušek
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Ondřej
authors.initials: O
authors.lastname: Petrák
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Karol
authors.initials: K
authors.lastname: Čurila
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Petr
authors.initials: P
authors.lastname: Waldauf
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: František
authors.initials: F
authors.lastname: Bednář
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Tomáš
authors.initials: T
authors.lastname: Zelinka
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Robert
authors.initials: R
authors.lastname: Holaj
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Branislav
authors.initials: B
authors.lastname: Štrauch
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Šomlóová
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Miloš
authors.initials: M
authors.lastname: Táborský
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Jan
authors.initials: J
authors.lastname: Václavík
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Eva
authors.initials: E
authors.lastname: Kociánová
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Marian
authors.initials: M
authors.lastname: Branny
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Igor
authors.initials: I
authors.lastname: Nykl
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Otakar
authors.initials: O
authors.lastname: Jiravský
authors.affiliation: From the 3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., O.P., T.Z., R.H., B.Š., Z.Š., J.W.); Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (J.R., P.W., P.T., K.Č., F.B.); Department of Anesthesiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Department of Internal Medicine I, University Hospital Olomouc, Czech Republic (M.T., J.V., E.K.); and Cardiocentre, Nemocnice Podlesí, Třinec, Czech Republic (M.B., I.N., O.J.).
authors.forename: Jiří
authors.initials: J
authors.lastname: Widimský
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D019771:Axotomy / Q000379:methods; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation; D003404:Creatinine / Q000097:blood; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D007668:Kidney / Q000294:innervation* / Q000601:surgery; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D013148:Spironolactone / Q000627:therapeutic use*; D013562:Sympathectomy / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D013148:Spironolactone; D003404:Creatinine
keywords: hypertension resistant to conventional therapy; spironolactone; sympathetic denervation