Design and rationale of the PROTECT study: a placebo-controlled randomized study of the selective A1 adenosine receptor antagonist rolofylline for patients hospitalized with acute decompensated heart failure and volume overload to assess treatment effect on congestion and renal function

Journal of Cardiac Failure
Beth Davison WeatherleyPROTECT Steering Committee, Investigators, and Coordinators

Abstract

Current treatment for acute decompensated heart failure (ADHF) is associated with incomplete resolution of symptoms and signs, recurrent symptoms of heart failure in-hospital and after discharge and high mortality. Studies have consistently demonstrated an association between worsening renal function in ADHF and adverse outcomes. Adenosine A(1) receptor antagonists, such as rolofylline, appear in preliminary studies to produce potentially beneficial effects on natriuresis, diuresis, renal blood flow, and glomerular filtration rate. In a previous dose-finding study, rolofylline 30 mg intravenously daily for 3 days was associated with symptom improvement, less worsening of renal function, and trends toward lower 60-day rates of death or readmission for cardiovascular or renal causes. This manuscript describes the rationale underlying the design of the phase 3 PROTECT (Placebo-controlled Randomized study of the selective A(1) adenosine receptor antagonist rolofylline for patients hospitalized with acute heart failure and volume Overload to assess Treatment Effect on Congestion and renal funcTion) trial. Rolofylline 30 mg or matching placebo was given intravenously as a 4-hour continuous infusion on 3 consecutive days and the hospi...Continue Reading

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Citations

Oct 12, 2010·The New England Journal of Medicine·Barry M MassieUNKNOWN PROTECT Investigators and Committees
Mar 4, 2014·European Heart Journal·Mattia A E ValenteHans L Hillege
Oct 25, 2011·Expert Opinion on Investigational Drugs·Stefania GessiPier Andrea Borea
Jan 5, 2011·International Journal of Nephrology·Katerina KoniariJohn Parissis
Dec 5, 2015·European Journal of Heart Failure·Biniyam G DemisseiAdriaan A Voors
Sep 9, 2015·European Journal of Heart Failure·Ekaterina S OvchinnikovaEugene Berezikov
Oct 30, 2015·European Journal of Heart Failure·Johanna E EmmensAdriaan A Voors
Sep 9, 2010·European Journal of Heart Failure·Piotr PonikowskiMarco Metra
Nov 22, 2013·European Journal of Heart Failure·Sven MeyerAdriaan A Voors
Aug 1, 2015·European Journal of Heart Failure·Elke PlatzJohn J McMurray
Jun 18, 2015·European Journal of Heart Failure·Robert J MentzChristopher M O'Connor
Feb 24, 2011·Expert Opinion on Pharmacotherapy·Marco MetraLivio Dei Cas
May 9, 2015·JACC. Heart Failure·Beth A DavisonUNKNOWN PROTECT and RELAX-AHF Executive Committees
Jul 28, 2016·International Journal of Cardiology·Jasper TrompPeter van der Meer
Mar 19, 2013·Journal of the American College of Cardiology·Peter van der MeerAdriaan A Voors
Nov 9, 2016·The American Journal of Cardiology·Jasper TrompPeter van der Meer
Jun 19, 2017·JACC. Heart Failure·Jasper TrompPeter van der Meer
Sep 26, 2013·European Heart Journal. Acute Cardiovascular Care·Katerina KoniariMaria Anastasiou-Nana
Aug 19, 2015·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Jozine M ter MaatenAdriaan A Voors
Nov 28, 2013·Circulation. Heart Failure·Michael M GivertzAdriaan A Voors
Jan 11, 2017·Circulation. Heart Failure·Koen W StrengPeter van der Meer
Feb 1, 2019·Circulation Journal : Official Journal of the Japanese Circulation Society·Hiroki NakanoUNKNOWN NaDEF Investigators
Feb 28, 2020·The Cochrane Database of Systematic Reviews·Meaghan LunneyPietro Ravani
Feb 22, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·John R TeerlinkBarry M Massie
Mar 3, 2017·European Journal of Heart Failure·Biniyam G DemisseiAdriaan A Voors
Dec 8, 2010·Heart Failure Reviews·Savina Nodari, Alberto Palazzuoli

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