TY  - JOUR
AU  - Imazio, Massimo
AU  - Belli, Riccardo
AU  - Brucato, Antonio
AU  - Ferrazzi, Paolo
AU  - Patrini, Davide
AU  - Martinelli, Luigi
AU  - Polizzi, Vincenzo
AU  - Cemin, Roberto
AU  - Leggieri, Anna
AU  - Caforio, Alida L. P.
AU  - Finkelstein, Yaron
AU  - Hoit, Brian
AU  - Maisch, Bernhard
AU  - Mayosi, Bongani M.
AU  - Oh, Jae K.
AU  - Ristic, Arsen D.
AU  - Seferovic, Petar
AU  - Spodick, David H.
AU  - Adler, Yehuda
PY  - 2013
UR  - https://vinar.vin.bg.ac.rs/handle/123456789/5567
AB  - Background The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing GT = 70 kg and 0.5 mg once for patients weighing LT 70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials. gov Identifier:
T2  - American Heart Journal
T1  - Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation
VL  - 166
IS  - 1
SP  - 13
EP  - U37
DO  - 10.1016/j.ahj.2013.03.025
ER  - 

@article{
author = "Imazio, Massimo and Belli, Riccardo and Brucato, Antonio and Ferrazzi, Paolo and Patrini, Davide and Martinelli, Luigi and Polizzi, Vincenzo and Cemin, Roberto and Leggieri, Anna and Caforio, Alida L. P. and Finkelstein, Yaron and Hoit, Brian and Maisch, Bernhard and Mayosi, Bongani M. and Oh, Jae K. and Ristic, Arsen D. and Seferovic, Petar and Spodick, David H. and Adler, Yehuda",
year = "2013",
abstract = "Background The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing GT = 70 kg and 0.5 mg once for patients weighing LT 70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials. gov Identifier:",
journal = "American Heart Journal",
title = "Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation",
volume = "166",
number = "1",
pages = "13-U37",
doi = "10.1016/j.ahj.2013.03.025"
}

Imazio, M., Belli, R., Brucato, A., Ferrazzi, P., Patrini, D., Martinelli, L., Polizzi, V., Cemin, R., Leggieri, A., Caforio, A. L. P., Finkelstein, Y., Hoit, B., Maisch, B., Mayosi, B. M., Oh, J. K., Ristic, A. D., Seferovic, P., Spodick, D. H.,& Adler, Y.. (2013). Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. in American Heart Journal, 166(1), 13-U37.
https://doi.org/10.1016/j.ahj.2013.03.025

Imazio M, Belli R, Brucato A, Ferrazzi P, Patrini D, Martinelli L, Polizzi V, Cemin R, Leggieri A, Caforio ALP, Finkelstein Y, Hoit B, Maisch B, Mayosi BM, Oh JK, Ristic AD, Seferovic P, Spodick DH, Adler Y. Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. in American Heart Journal. 2013;166(1):13-U37.
doi:10.1016/j.ahj.2013.03.025 .

Imazio, Massimo, Belli, Riccardo, Brucato, Antonio, Ferrazzi, Paolo, Patrini, Davide, Martinelli, Luigi, Polizzi, Vincenzo, Cemin, Roberto, Leggieri, Anna, Caforio, Alida L. P., Finkelstein, Yaron, Hoit, Brian, Maisch, Bernhard, Mayosi, Bongani M., Oh, Jae K., Ristic, Arsen D., Seferovic, Petar, Spodick, David H., Adler, Yehuda, "Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation" in American Heart Journal, 166, no. 1 (2013):13-U37,
https://doi.org/10.1016/j.ahj.2013.03.025 . .

TY  - JOUR
AU  - Mitrovic, Veselin
AU  - Seferovic, Petar M.
AU  - Simeunovic, Dejan
AU  - Ristic, Arsen D.
AU  - Miric, Milutin
AU  - Moiseyev, Valentin S.
AU  - Kobalava, Zhanna
AU  - Nitsche, Klaus
AU  - Forssmann, Wolf-Georg
AU  - Luess, Hartmut
AU  - Meyer, Markus
PY  - 2006
UR  - https://vinar.vin.bg.ac.rs/handle/123456789/3125
AB  - Aims Ularitide is a synthetic form of urodilatin, a natriuretic peptide produced in the kidney with vasodilating, natriuretic, and diuretic effects, that offers promise for the management of decompensated heart failure (DHF). We assessed the efficacy and safety of ularitide in treating patients with DHF. Methods and results In this Phase II randomized, double-blind, placebo-controlled trial, 221 DHF patients received either placebo (n=53) or ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion. At 6 h, ularitide demonstrated a significant decrease in pulmonary capillary wedge pressure (P=0.052, P=0.000004, P=0.000002, respectively) and improved dyspnoea score in the 7.5, 15, and 30 ng/kg/min ularitide group (P=0.0026, P=0.0026, P=0.0013, respectively). Ularitide reduced systemic vascular resistance and increased cardiac index for the 15 and 30 ng/kg/min groups (P=0.017, P=0.00002, respectively). Systolic blood pressure (BP) decreased dose dependency. Heart rate and serum creatinine were unchanged through day 3. Most frequently reported drug-related adverse events through day 3 in all ularitide groups were dose-dependent BP decrease and hypotension. Conclusion Ularitide lowered cardiac filling pressures and improved dyspnoea without apparent early deleterious effects on renal function in DHF patients. These results suggest that ularitide may play a role in the management of DHF.
T2  - European Heart Journal
T1  - Haemodynamic and clinical effects of ularitide in decompensated heart failure
VL  - 27
IS  - 23
SP  - 2823
EP  - 2832
DO  - 10.1093/eurheartj/ehl337
ER  - 

@article{
author = "Mitrovic, Veselin and Seferovic, Petar M. and Simeunovic, Dejan and Ristic, Arsen D. and Miric, Milutin and Moiseyev, Valentin S. and Kobalava, Zhanna and Nitsche, Klaus and Forssmann, Wolf-Georg and Luess, Hartmut and Meyer, Markus",
year = "2006",
abstract = "Aims Ularitide is a synthetic form of urodilatin, a natriuretic peptide produced in the kidney with vasodilating, natriuretic, and diuretic effects, that offers promise for the management of decompensated heart failure (DHF). We assessed the efficacy and safety of ularitide in treating patients with DHF. Methods and results In this Phase II randomized, double-blind, placebo-controlled trial, 221 DHF patients received either placebo (n=53) or ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion. At 6 h, ularitide demonstrated a significant decrease in pulmonary capillary wedge pressure (P=0.052, P=0.000004, P=0.000002, respectively) and improved dyspnoea score in the 7.5, 15, and 30 ng/kg/min ularitide group (P=0.0026, P=0.0026, P=0.0013, respectively). Ularitide reduced systemic vascular resistance and increased cardiac index for the 15 and 30 ng/kg/min groups (P=0.017, P=0.00002, respectively). Systolic blood pressure (BP) decreased dose dependency. Heart rate and serum creatinine were unchanged through day 3. Most frequently reported drug-related adverse events through day 3 in all ularitide groups were dose-dependent BP decrease and hypotension. Conclusion Ularitide lowered cardiac filling pressures and improved dyspnoea without apparent early deleterious effects on renal function in DHF patients. These results suggest that ularitide may play a role in the management of DHF.",
journal = "European Heart Journal",
title = "Haemodynamic and clinical effects of ularitide in decompensated heart failure",
volume = "27",
number = "23",
pages = "2823-2832",
doi = "10.1093/eurheartj/ehl337"
}

Mitrovic, V., Seferovic, P. M., Simeunovic, D., Ristic, A. D., Miric, M., Moiseyev, V. S., Kobalava, Z., Nitsche, K., Forssmann, W., Luess, H.,& Meyer, M.. (2006). Haemodynamic and clinical effects of ularitide in decompensated heart failure. in European Heart Journal, 27(23), 2823-2832.
https://doi.org/10.1093/eurheartj/ehl337

Mitrovic V, Seferovic PM, Simeunovic D, Ristic AD, Miric M, Moiseyev VS, Kobalava Z, Nitsche K, Forssmann W, Luess H, Meyer M. Haemodynamic and clinical effects of ularitide in decompensated heart failure. in European Heart Journal. 2006;27(23):2823-2832.
doi:10.1093/eurheartj/ehl337 .

Mitrovic, Veselin, Seferovic, Petar M., Simeunovic, Dejan, Ristic, Arsen D., Miric, Milutin, Moiseyev, Valentin S., Kobalava, Zhanna, Nitsche, Klaus, Forssmann, Wolf-Georg, Luess, Hartmut, Meyer, Markus, "Haemodynamic and clinical effects of ularitide in decompensated heart failure" in European Heart Journal, 27, no. 23 (2006):2823-2832,
https://doi.org/10.1093/eurheartj/ehl337 . .