Effects of Tezosentan on Symptoms and Clinical Outcomes in Patients With Acute Heart Failure: The VERITAS Randomized Controlled Trials
John J.V. McMurray,John R. Teerlink,Gadi Cotter,Robert C. Bourge,John G.F. Cleland,Guillaume Jondeau,Henry Krum,Marco Metra,Christopher M. O'Connor,John D. Parker,Guillermo Torre-Amione,Dirk J. van Veldhuisen,James Lewsey,Aline Frey,Maurizio Rainisio,Isaac Kobrin +15 more
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The endothelin receptor antagonist tezosentan did not improve symptoms or clinical outcomes in patients with acute heart failure and was not associated with worse outcomes.Abstract:
ContextPlasma concentrations of the vasoconstrictor peptide endothelin-1 are increased in patients with heart failure, and higher concentrations are associated with worse outcomes. Tezosentan is an intravenous short-acting endothelin receptor antagonist that has favorable hemodynamic actions in heart failure.ObjectiveTo determine if tezosentan improves outcomes in patients with acute heart failure.Design, Setting, and ParticipantsThe Value of Endothelin Receptor Inhibition With Tezosentan in Acute Heart Failure Studies, 2 independent, identical, and concurrent randomized, double-blind, placebo-controlled, parallel-group trials conducted from April 2003 through January 2005 at sites in Australia, Europe, Israel, and North America. Patients admitted within the previous 24 hours with persisting dyspnea and a respiratory rate of 24/min or greater were eligible provided they fulfilled 2 of 4 criteria: (1) elevated plasma concentrations of B-type or N-terminal pro–B-type natriuretic peptide, (2) clinical pulmonary edema, (3) radiologic pulmonary congestion or edema, or (4) left ventricular systolic dysfunction.InterventionInfusion of tezosentan (5 mg/h for 30 minutes, followed by 1 mg/h for 24 to 72 hours [n = 730]) or placebo (n = 718).Main Outcome MeasuresThe coprimary end points were change in dyspnea (measured at 3, 6, and 24 hours using a visual analog scale from 0-100) over 24 hours (as area under the curve) in the individual trials and incidence of death or worsening heart failure at 7 days in both trials combined.ResultsOf the 1435 patients who received treatment as assigned, 855 (60%) were men; mean age was 70 years. Mean left ventricular ejection fraction (measured in 779 patients [54%]) was 29% (SD, 11%). Baseline dyspnea scores were similar in the 2 treatment groups. Tezosentan did not improve dyspnea more than placebo in either trial, with a mean treatment difference of −12 (95% confidence interval [CI], −105 to 81) mm · h (P = .80) in the first trial and −25 (95% CI, −119 to 69) mm · h (P = .60) in the second. The incidence of death or worsening heart failure at 7 days in the combined trials was 26% in each treatment group (odds ratio, 0.99; 95% confidence interval, 0.82-1.21; P = .95).ConclusionThe endothelin receptor antagonist tezosentan did not improve symptoms or clinical outcomes in patients with acute heart failure.Trial Registrationclinicaltrials.gov Identifiers: NCT00525707 (VERITAS-1) and NCT00524433 (VERITAS-2).read more
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Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial
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Structured telephone support or telemonitoring programmes for patients with chronic heart failure
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TL;DR: Structured telephone support and telemonitoring are effective in reducing the risk of all-cause mortality and CHF-related hospitalisations in patients with CHF; they improve quality of life, reduce costs, and evidence-based prescribing.
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TL;DR: Current available assessment modalities combined with recent advances in cardiovascular therapies provide present-day opportunities to improve post-discharge outcomes, but further investigation into pathophysiologic targets and novel approaches to clinical trial design are needed.
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TL;DR: Rolofylline did not have a favorable effect with respect to the primary clinical composite end point, nor did it improve renal function or 60-day outcomes, and does not show promise in the treatment of acute heart failure with renal dysfunction.
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Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association.
Marvin A. Konstam,Michael S. Kiernan,Daniel Bernstein,Biykem Bozkurt,Miriam Jacob,Navin K. Kapur,Robb D. Kociol,Eldrin F. Lewis,Mandeep R. Mehra,Francis D. Pagani,Amish N. Raval,Carey Ward +11 more
TL;DR: RHF is a complex syndrome including diverse causes, pathways, and pathological processes and multiple hemodynamic and biochemical markers are associated with worsening RHF and can serve to guide clinical assessment and therapeutic decision making.
References
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Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness
James A. Hill,Daniel F. Pauly,Debra R. Olitsky,Stuart D. Russell,Christopher M. O'Connor,Beth Patterson,Uri Elkayam,Salman Khan,Lynne W. Stevenson,Kimberly Brooks,Lynne E. Wagoner,Ginger Conway,Todd M. Koelling,Carol Van Huysen,Joshua M. Hare,Elayne Breton,Kirkwood F. Adams,Jana M. Glotzer,Gregg C. Fonarow,Michele A. Hamilton,Julie M. Sorg,Mark H. Drazner,Shannon Hoffman,Leslie W. Miller,Judith A. Graziano,Mary Ellen Berman,Robert P. Frantz,Karen A. Hartman,Carl V. Leier,William T. Abraham,Laura Yamokoski,Thomas G. DiSalvo,Janice Camuso,Mihai Gheorghiade,Karen Fachet,Alain Heroux,Jin Kim Soo,J. Wayne Warnica,Jane Grant,Mian A. Hasan,Lydia Withrow,James B. Young,Barbara Gus,Javed Butler,Laurie Hawkins,Barry K. Rayburn,Jessica Robinson,Ileana L. Piña,Lori Shelby,Joseph G. Rogers,Heidi Craddock,Melvin Tonkon,Shane Miller,Teresa DeMarco,Debra Lau,Maryl R. Johnson,Cassondra Vander Ark +56 more
TL;DR: Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures with or without the PAC, which reached significance for the time trade-off at all time points after randomization.
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Markku S. Nieminen,Silvia G. Priori,Maria Angeles Alonso Garcia,Andrzej Budaj,Enrique Fernandez Burgos,John Lekakis,Gianfranco Mazzotta,Otto A. Smiseth,Kenneth Dickstein,María G. Crespo-Leiro,Roberto Ferrari +10 more
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Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial.
Michael S. Cuffe,Robert M. Califf,Kirkwood F. Adams,Raymond L. Benza,Robert C. Bourge,Wilson S. Colucci,Barry M. Massie,Christopher M. O'Connor,Ileana L. Piña,Rebecca Quigg,Marc A. Silver,Mihai Gheorghiade +11 more
TL;DR: In this article, the authors evaluated the effect of intravenous milrinone on intermediate-term clinical outcomes of patients with chronic heart failure in a randomized, double-blind, placebo-controlled trial.
Journal Article
Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: A randomized controlled trial
Journal ArticleDOI
Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group.
Wilson S. Colucci,Uri Elkayam,D P Horton,William T. Abraham,Robert C. Bourge,A.D. Johnson,Lynne E. Wagoner,Michael M. Givertz,C S Liang,M Neibaur,W H Haught,Thierry H. LeJemtel +11 more
TL;DR: Improvements in global clinical status, dyspnea, and fatigue were sustained with nesiritide therapy for up to seven days and were similar to those observed with standard intravenous therapy for heart failure.
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