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https://www.readbyqxmd.com/read/27873428/data-and-safety-monitoring-board-evaluation-and-management-of-a-renal-adverse-event-signal-in-topcat
#1
REVIEW
Michael R Bristow, Kavita Sharma, Susan F Assmann, Stuart Linas, Bernard J Gersh, Christine Grady, Madeline Murguia Rice, Steven Singh, Robin Boineau, Sonja M McKinlay, Barry H Greenberg
Clinical trial Data and Safety Monitoring Boards (DSMBs) have a primary obligation of ensuring study participant safety, while maintaining trial integrity. The role of DSMBs is expanding, and ideally should include post-hoc reporting of deliberative processes related to clinically important safety issues or factors that could impact on future trial designs. We describe how the TOPCAT DSMB detected, investigated, and adjudicated an unexpectedly large renal adverse event signal midway through the trial, and offer general guidelines for dealing with similar unanticipated occurrences in future trials...
November 21, 2016: European Journal of Heart Failure
https://www.readbyqxmd.com/read/27753859/sp-01-3-aldosterone-antagonists-in-heart-failure
#2
Colin Johnston
Aldosterone's deleterious pathophysiological effects on the cardiovascular system if blocked by mineralcorticord antagonists (MRAs) logically should lead to improvement in heart function and outcomes in heart failure (HF). The first trial to test this hypothesis was tthe RALES trial in 1999 which treated patients with class III-IV HF with spironolactone. It showed significant reduction in mortality and cardiovascular hospitalzation rates. This was confirmed & extended in EMHASIS-HF RCT with classs II-III being treated with ACEIs & BB who received placebo or elperinone (a MRA) with again a statistically significant fall in mortality & hospitalization...
September 2016: Journal of Hypertension
https://www.readbyqxmd.com/read/27747305/detection-and-management-of-geographic-disparities-in-the-topcat-trial-lessons-learned-and-derivative-recommendations
#3
Michael R Bristow, Jorge Silva Enciso, Bernard J Gersh, Christine Grady, Madeline Murguia Rice, Steven Singh, George Sopko, Robin Boineau, Yves Rosenberg, Barry H Greenberg
TOPCAT was a multinational clinical trial of 3,445 heart failure with preserved ejection fraction (HFpEF) patients that enrolled in 233 sites in six countries in North America, Eastern Europe and South America. Patients with a heart failure hospitalization in the last 12 months or an elevated B-type natriuretic peptide (BNP) were randomized to the mineralocorticoid receptor antagonist spironolactone vs. placebo. Sites in Russia and the Republic of Georgia provided the majority of early enrollment, primarily based on the hospitalization criterion since BNP levels were initially unavailable there...
April 2016: JACC. Basic to Translational Science
https://www.readbyqxmd.com/read/27643096/sp-01-3-aldosterone-antagonists-in-heart-failure
#4
Colin Johnston
Aldosterone's deleterious pathophysiological effects on the cardiovascular system if blocked by mineralcorticord antagonists (MRAs) logically should lead to improvement in heart function and outcomes in heart failure (HF). The first trial to test this hypothesis was tthe RALES trial in 1999 which treated patients with class III-IV HF with spironolactone. It showed significant reduction in mortality and cardiovascular hospitalzation rates. This was confirmed & extended in EMHASIS-HF RCT with classs II-III being treated with ACEIs & BB who received placebo or elperinone (a MRA) with again a statistically significant fall in mortality & hospitalization...
September 2016: Journal of Hypertension
https://www.readbyqxmd.com/read/27612005/a-tentative-interpretation-of-the-topcat-trial-based-on-randomized-evidence-from-the-brain-natriuretic-peptide-stratum-analysis
#5
Nicolas Girerd, João Pedro Ferreira, Patrick Rossignol, Faiez Zannad
No abstract text is available yet for this article.
December 2016: European Journal of Heart Failure
https://www.readbyqxmd.com/read/27075872/after-topcat-what-to-do-now-in-heart-failure-with-preserved-ejection-fraction
#6
REVIEW
Akshay S Desai, Pardeep S Jhund
Although patients with heart failure and preserved ejection fraction (HF-PEF) represent nearly half of the population with chronic heart failure, few evidence-based medical therapies are available. The neutral overall results of the TOPCAT trial of spironolactone in HF-PEF leave clinicians who treat heart failure with an ongoing clinical dilemma. In this review, we outline an approach to the clinical management of the patient with HF-PEF synthesizing data from available clinical trials and expert consensus.
November 1, 2016: European Heart Journal
https://www.readbyqxmd.com/read/27056882/prognostic-relevance-of-left-atrial-dysfunction-in-heart-failure-with-preserved-ejection-fraction
#7
RANDOMIZED CONTROLLED TRIAL
Angela B S Santos, Gabriela Querejeta Roca, Brian Claggett, Nancy K Sweitzer, Sanjiv J Shah, Inder S Anand, James C Fang, Michael R Zile, Bertram Pitt, Scott D Solomon, Amil M Shah
BACKGROUND: Left atrial (LA) size is an established marker of risk for adverse outcomes in heart failure with preserved ejection fraction (HFpEF). However, the independent prognostic importance of LA function in HFpEF is not known. METHODS AND RESULTS: We assessed LA function measured by speckle-tracking echocardiography in 357 patients with HFpEF enrolled in the Treatment Of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial who were in sinus rhythm at the time of echocardiography...
April 2016: Circulation. Heart Failure
https://www.readbyqxmd.com/read/27039126/qrs-duration-is-a-predictor-of-adverse%C3%A2-outcomes-in-heart-failure-with%C3%A2-preserved-ejection-fraction
#8
Jacob Joseph, Brian C Claggett, Inder S Anand, Jerome L Fleg, Thao Huynh, Akshay S Desai, Scott D Solomon, Eileen O'Meara, Sonja Mckinlay, Bertram Pitt, Marc A Pfeffer, Eldrin F Lewis
OBJECTIVES: This study examined the relationship between baseline QRS duration and clinical outcomes in subjects enrolled in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial. BACKGROUND: Heart failure with preserved ejection fraction (HFPEF) is a heterogeneous clinical syndrome. Whether QRS duration identifies HFPEF subjects at an increased risk of adverse outcomes has not been well studied. METHODS: QRS duration was analyzed as a dichotomous variable (≥120 ms or <120 ms) and as a continuous variable to determine its relation to the primary outcome (composite of cardiovascular death, aborted cardiac arrest, or HF hospitalization [HFH]) and to each component of the primary outcome...
June 2016: JACC. Heart Failure
https://www.readbyqxmd.com/read/26962133/impact-of-spironolactone-on-longitudinal-changes-in-health-related-quality-of-life-in-the-treatment-of-preserved-cardiac-function-heart-failure-with-an-aldosterone-antagonist-trial
#9
RANDOMIZED CONTROLLED TRIAL
Eldrin F Lewis, Hae-Young Kim, Brian Claggett, John Spertus, John F Heitner, Susan F Assmann, Christopher T Kenwood, Scott D Solomon, Akshay S Desai, James C Fang, Sonia A McKinlay, Bertram A Pitt, Marc A Pfeffer
BACKGROUND: Heart failure (HF) with preserved ejection fraction patients have equally impaired health-related quality of life (HRQL) compared with those with HF with reduced ejection fraction, but limited studies have evaluated the impact of therapies on changes in HRQL. METHODS AND RESULTS: Patients ≥50 years of age, with symptomatic HF and left ventricular ejection fraction ≥45%, were enrolled in Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) and randomized to spironolactone or placebo...
March 2016: Circulation. Heart Failure
https://www.readbyqxmd.com/read/26475142/prognostic-importance-of-changes-in-cardiac-structure-and-function-in-heart-failure-with-preserved-ejection-fraction-and-the-impact-of-spironolactone
#10
RANDOMIZED CONTROLLED TRIAL
Amil M Shah, Brian Claggett, Nancy K Sweitzer, Sanjiv J Shah, Anita Deswal, Inder S Anand, Jerome L Fleg, Bertram Pitt, Marc A Pfeffer, Scott D Solomon
BACKGROUND: Limited data exist regarding the impact of aldosterone antagonist therapy on cardiac structure and function in heart failure with preserved ejection fraction and on the prognostic relevance of changes in cardiac structure and function in heart failure with preserved ejection fraction. METHODS AND RESULTS: Cardiac structure and function were assessed by quantitative echocardiography at baseline and at 12- to 18-month follow-up in 239 patients with heart failure with preserved ejection fraction (left ventricular [LV] ejection fraction [LVEF] ≥45%) enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial...
November 2015: Circulation. Heart Failure
https://www.readbyqxmd.com/read/26408016/spironolactone-for-management-of-heart-failure-with-preserved-ejection-fraction-whither-to-after-topcat
#11
REVIEW
Sumeet S Mitter, Sanjiv J Shah
Mineralocorticoid receptor antagonists (MRAs) represent an attractive class of drugs for the treatment of heart failure with preserved ejection fraction (HFpEF) because of the deleterious cardiovascular effects of aldosterone and because MRAs combat myocardial fibrosis and improve cardiac structure/function and vascular health. Recently, the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study, a randomized, double-blind clinical trial of spironolactone versus placebo, was conducted in 3445 patients with symptomatic HFpEF...
November 2015: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/26374849/influence-of-ejection-fraction-on-outcomes-and-efficacy-of-spironolactone-in-patients-with-heart-failure-with-preserved-ejection-fraction
#12
Scott D Solomon, Brian Claggett, Eldrin F Lewis, Akshay Desai, Inder Anand, Nancy K Sweitzer, Eileen O'Meara, Sanjiv J Shah, Sonja McKinlay, Jerome L Fleg, George Sopko, Bertram Pitt, Marc A Pfeffer
AIMS: While mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45% or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone...
February 1, 2016: European Heart Journal
https://www.readbyqxmd.com/read/26130119/prognostic-importance-of-impaired-systolic-function-in-heart-failure-with-preserved-ejection-fraction-and-the-impact-of-spironolactone
#13
RANDOMIZED CONTROLLED TRIAL
Amil M Shah, Brian Claggett, Nancy K Sweitzer, Sanjiv J Shah, Inder S Anand, Li Liu, Bertram Pitt, Marc A Pfeffer, Scott D Solomon
BACKGROUND: Impairment in left ventricular systolic function has been described in heart failure (HF) with preserved ejection fraction (HFpEF), but its prognostic relevance is not known. We determined whether left ventricular longitudinal strain (LS) is predictive of cardiovascular outcomes in HFpEF beyond clinical and conventional echocardiographic measures. METHODS AND RESULTS: LS was assessed by 2-dimensional speckle-tracking echocardiography at baseline in 447 patients with HFpEF enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial...
August 4, 2015: Circulation
https://www.readbyqxmd.com/read/26112224/a-pilot-randomised-controlled-trial-of-personalised-care-after-treatment-for-prostate-cancer-topcat-p-nurse-led-holistic-needs-assessment-and-individualised-psychoeducational-intervention-study-protocol
#14
RANDOMIZED CONTROLLED TRIAL
Marian Andrei Stanciu, Caroline Morris, Matt Makin, Eila Watson, Jenna Bulger, Richard Evans, Julia Hiscock, Zoë Hoare, Rhiannon Tudor Edwards, Richard David Neal, Clare Wilkinson
INTRODUCTION: Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings...
2015: BMJ Open
https://www.readbyqxmd.com/read/26075843/-effect-of-spironolactone-in-patients-with-heart-failure-and-preserved-left-ventricular-function-topcat-study
#15
REVIEW
Jiří Widimský
The TOPCAT study followed the effect of spironolactone on a chronic heart failure with a preserved left ventricular ejection fraction. The study did not find any impact on the primary goal of the study, i.e. a combination of cardiovascular mortality, managed cardiac arrest or hospitalization rate for heart failure treatment. The only finding of the study was the decrease in hospitalization rates for a heart failure. A post hoc analysis, however, identified a significant difference between patients from the Americas (USA, Canada, Argentina, Brazil) on the one hand and those from Russia/Georgia on the other...
May 2015: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/25648577/baseline-distribution-of-participants-with-depression-and-impaired-quality-of-life-in-the-treatment-of-preserved-cardiac-function-heart-failure-with-an-aldosterone-antagonist-trial
#16
RANDOMIZED CONTROLLED TRIAL
Carine E Hamo, John F Heitner, Marc A Pfeffer, Hae-Young Kim, Christopher T Kenwood, Susan F Assmann, Scott D Solomon, Robin Boineau, Jerome L Fleg, John A Spertus, Eldrin F Lewis
BACKGROUND: Previous studies have demonstrated the psychosocial effect of heart failure in patients with reduced ejection fraction. However, the effects on patients with preserved ejection fraction have not yet been elucidated. This study aimed to determine the baseline characteristics of participants with heart failure with preserved ejection fraction as it relates to impaired quality of life (QOL) and depression, identify predictors of poor QOL and depression, and determine the correlation between QOL and depression...
March 2015: Circulation. Heart Failure
https://www.readbyqxmd.com/read/25572305/preliminary-investigation-of-the-thermal-antinociceptive-effects-of-codeine-in-cats
#17
RANDOMIZED CONTROLLED TRIAL
Paulo V M Steagall, Beatriz P Monteiro, Anne-Marie Lavoie, Eric Troncy
OBJECTIVES: The aim of this study was to evaluate the potential thermal antinociceptive effects of oral administration of a single dose of codeine in cats compared with positive (buprenorphine) and negative (saline 0.9%) controls. METHODS: Six adult healthy cats weighing 5.14 ± 0.6 kg were used. Skin temperature and thermal thresholds (TTs) were evaluated using a wireless device (Topcat Metrology) at baseline, 0.5, 1, 3, 6 and 10 h after treatment. In period 1, TTs were evaluated after subcutaneous administration of saline 0...
December 2015: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/25445137/heart-failure-regional-patient-variability-and-outcomes-in-topcat
#18
(no author information available yet)
No abstract text is available yet for this article.
January 2015: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/25424015/-the-topcat-study
#19
RANDOMIZED CONTROLLED TRIAL
Alessandro Boccanelli, Giovanni Pulignano
No abstract text is available yet for this article.
October 2014: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/25406305/regional-variation-in-patients-and-outcomes-in-the-treatment-of-preserved-cardiac-function-heart-failure-with-an-aldosterone-antagonist-topcat-trial
#20
RANDOMIZED CONTROLLED TRIAL
Marc A Pfeffer, Brian Claggett, Susan F Assmann, Robin Boineau, Inder S Anand, Nadine Clausell, Akshay S Desai, Rafael Diaz, Jerome L Fleg, Ivan Gordeev, John F Heitner, Eldrin F Lewis, Eileen O'Meara, Jean-Lucien Rouleau, Jeffrey L Probstfield, Tamaz Shaburishvili, Sanjiv J Shah, Scott D Solomon, Nancy K Sweitzer, Sonja M McKinlay, Bertram Pitt
BACKGROUND: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome (time to cardiovascular death, aborted cardiac arrest, or hospitalization for management of heart failure) compared with patients receiving placebo. In a post hoc analysis, an ≈4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States, Canada, Brazil, and Argentina (the Americas)...
January 6, 2015: Circulation
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