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https://www.readbyqxmd.com/read/29228101/spironolactone-and-resistant-hypertension-in-heart-failure-with-preserved-ejection-fraction
#1
P Rossignol, B Claggett, J Liu, O Vardeny, B Pitt, F Zannad, S Solomon
Background: Recent evidence suggests that the mineralocorticoid receptor antagonist spironolactone should be the preferred fourth line antihypertensive treatment in resistant hypertension (RHTN). Whether spironolactone improves blood pressure (BP) control in heart failure with preserved ejection fraction (HFpEF) and RHTN is unknown. Methods: We identified patients with RHTN, defined as baseline systolic blood pressure (SBP) between 140 and 160 mmHg on 3 or more medications, in the Americas cohort of the TOPCAT trial, in which patients with HFpEF were randomized to spironolactone vs...
December 7, 2017: American Journal of Hypertension
https://www.readbyqxmd.com/read/29191321/abdominal-obesity-is-associated-with%C3%A2-an%C3%A2-increased-risk-of-all-cause-mortality-in-patients-with-hfpef
#2
RANDOMIZED CONTROLLED TRIAL
Tetsuro Tsujimoto, Hiroshi Kajio
BACKGROUND: There is a lack of studies that evaluate the association between abdominal obesity and subsequent outcomes in patients with heart failure with preserved ejection fraction (HFpEF). OBJECTIVES: The present study aimed to assess the association between abdominal obesity and risk of all-cause mortality in patients with HFpEF. METHODS: The present study used data from the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial...
December 5, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/29148144/systolic-blood-pressure-and-cardiovascular-outcomes-in-heart-failure-with-preserved-ejection-fraction-an-analysis-of-the-topcat-trial
#3
Senthil Selvaraj, Brian Claggett, Sanjiv J Shah, Inder Anand, Jean L Rouleau, Akshay S Desai, Eldrin F Lewis, Bertram Pitt, Nancy K Sweitzer, Marc A Pfeffer, Scott D Solomon
AIMS: Recent guidelines have advocated for stricter systolic blood pressure (SBP) control in heart failure with preserved ejection fraction (HFpEF), though data regarding the optimal SBP in HFpEF are sparse. METHODS AND RESULTS: We analysed participants from the Americas from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study with available baseline and 8-week visit SBP data (n = 1645). We related baseline SBP to several efficacy and safety outcomes...
November 16, 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/29094152/association-of-serial-kansas-city-cardiomyopathy-questionnaire-assessments-with-death-and-hospitalization-in-patients-with-heart-failure-with-preserved-and-reduced-ejection-fraction-a-secondary-analysis-of-2-randomized-clinical-trials
#4
Yashashwi Pokharel, Yevgeniy Khariton, Yuanyuan Tang, Michael E Nassif, Paul S Chan, Suzanne V Arnold, Philip G Jones, John A Spertus
Importance: While there is increasing emphasis on incorporating patient-reported outcome measures in routine care for patients with heart failure (HF), how best to interpret longitudinally collected patient-reported outcome measures is unknown. Objective: To examine the strength of association between prior, current, or a change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores with death and hospitalization in patients with HF with preserved (HFpEF) and reduced (HFrEF) ejection fractions...
November 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29051160/the-prognostic-significance-of-diabetes-and-microvascular-complications-in-patients-with-heart-failure-with-preserved-ejection-fraction
#5
Pratik B Sandesara, Wesley T O'Neal, Heval M Kelli, Ayman Samman-Tahhan, Muhammad Hammadah, Arshed A Quyyumi, Laurence S Sperling
OBJECTIVE: This study examined the prognostic significance of diabetes and microvascular complications in patients with heart failure with preserved ejection fraction (HFpEF). RESEARCH DESIGN AND METHODS: This analysis included 3,385 patients (mean age 69 ± 9.6 years; 49% male; 89% white) with HFpEF from the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial (TOPCAT). Diabetes and microvascular complications were ascertained by self-reported history and medical record review...
October 19, 2017: Diabetes Care
https://www.readbyqxmd.com/read/29041892/-randomized-controlled-trials-in-patients-with-heart-failure-in-russia-following-the-study-topcat-what-awaits-us-in-the-future
#6
M Y Lopatin
No abstract text is available yet for this article.
August 2017: Kardiologiia
https://www.readbyqxmd.com/read/29034087/spironolactone-in-cardiovascular-disease-an-expanding-universe
#7
REVIEW
John W Funder
Spironolactone has been marketed for over half a century as a 'potassium-sparing diuretic', used primarily in patients with ascites. With the realization that primary aldosteronism is the most common (5-13%) form of secondary hypertension, it has become widely used as a mineralocorticoid receptor antagonist. More recently, in the wake of the RALES trial, spironolactone in addition to standard therapy has been shown to be very beneficial in heart failure with a reduced ejection fraction. Despite the failure of the TOPCAT trial, spironolactone is being increasingly used in diastolic heart failure (i...
2017: F1000Research
https://www.readbyqxmd.com/read/29032132/prognostic-importance-of-temporal-changes-in-resting-heart-rate-in-heart-failure-and-preserved-ejection-fraction-from-the-topcat-study
#8
Ali Vazir, Brian Claggett, Bertram Pitt, Inder Anand, Nancy Sweitzer, James Fang, Jerome Fleg, Jean Rouleau, Sanjiv Shah, Marc A Pfeffer, Scott D Solomon
OBJECTIVES: The aim of this study was to examine the relationship between baseline heart rate (HR), change in HR from a preceding visit, and time-updated HR with subsequent outcomes in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial. BACKGROUND: Higher resting HR and increase in HR over time in patients with heart failure are associated with adverse outcomes...
October 4, 2017: JACC. Heart Failure
https://www.readbyqxmd.com/read/28647918/designing-future-clinical-trials-in-heart-failure-with-preserved-ejection-fraction-lessons-from-topcat
#9
REVIEW
Ravi B Patel, Sanjiv J Shah, Gregg C Fonarow, Javed Butler, Muthiah Vaduganathan
PURPOSE OF REVIEW: Spironolactone did not demonstrate benefit with respect to the primary composite endpoint in the global TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial in patients with chronic heart failure with preserved ejection fraction (HFpEF). We identify key lessons from the TOPCAT experience that can be applied to future HFpEF trials. RECENT FINDINGS: Subsequent analyses of TOPCAT have revealed marked regional heterogeneity in patient profiles, event rates, drug adherence, and treatment effects...
August 2017: Current Heart Failure Reports
https://www.readbyqxmd.com/read/28637881/physical-activity-and-prognosis-in-the-topcat-trial-treatment-of-preserved-cardiac-function-heart-failure-with-an-aldosterone-antagonist
#10
RANDOMIZED CONTROLLED TRIAL
Sheila M Hegde, Brian Claggett, Amil M Shah, Eldrin F Lewis, Inder Anand, Sanjiv J Shah, Nancy K Sweitzer, James C Fang, Bertram Pitt, Marc A Pfeffer, Scott D Solomon
BACKGROUND: Physical activity (PA) is inversely associated with adverse cardiovascular outcomes in healthy populations, but the impact of physical activity in patients with heart failure (HF) with preserved ejection fraction is less well characterized. METHODS: The baseline self-reported PA of 1751 subjects enrolled in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) was categorized as poor, intermediate, or ideal PA with American Heart Association criteria...
September 12, 2017: Circulation
https://www.readbyqxmd.com/read/28482692/heart-rate-and-the-risk-of-adverse-outcomes-in-patients-with-heart-failure-with-preserved-ejection-fraction
#11
Wesley T O'Neal, Pratik B Sandesara, Ayman Samman-Tahhan, Heval M Kelli, Muhammad Hammadah, Elsayed Z Soliman
Background Although high resting heart rates are associated with adverse outcomes in heart failure with reduced ejection, the reports for heart failure with preserved ejection fraction (HFpEF) are conflicting. Design A secondary analysis was conducted in order to examine the relationship between resting heart rate and adverse outcomes in 2705 patients (mean age = 68 ± 10 years; 47% men; 88% white) with HFpEF who were in sinus rhythm from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT)...
July 2017: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/28445660/spironolactone-metabolites-in-topcat-new-insights-into-regional-variation
#12
COMPARATIVE STUDY
Simon de Denus, Eileen O'Meara, Akshay S Desai, Brian Claggett, Eldrin F Lewis, Grégoire Leclair, Martin Jutras, Joël Lavoie, Scott D Solomon, Bertram Pitt, Marc A Pfeffer, Jean L Rouleau
No abstract text is available yet for this article.
April 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28444995/peripheral-artery-disease-and-risk-of-adverse-outcomes-in-heart-failure-with-preserved-ejection-fraction
#13
Pratik B Sandesara, Muhammad Hammadah, Ayman Samman-Tahhan, Heval M Kelli, Wesley T O'Neal
BACKGROUND: Peripheral artery disease (PAD) in heart failure with preserved ejection fraction (HFpEF) is associated with an increased mortality risk, but the risk of individual outcomes associated with PAD in this patient group is less clear. HYPOTHESIS: PAD is associated with adverse outcomes in HFpEF, including hospitalization and specific cardiovascular outcomes. METHODS: We examined the association between PAD and adverse outcomes in 3385 patients with HFpEF (mean age, 69 ± 9...
September 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28434933/assessing-the-eligibility-criteria-in-phase-iii-randomized-controlled-trials-of-drug-therapy-in-heart-failure-with-preserved-ejection-fraction-the-critical-play-off-between-a-pure-patient-phenotype-and-the-generalizability-of-trial-findings
#14
Hitesh C Patel, Carl Hayward, Jason N Dungu, Sofia Papadopoulou, Abdel Saidmeerasah, Robin Ray, Carlo Di Mario, Nesan Shanmugam, Martin R Cowie, Lisa J Anderson
AIMS: To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype, and survival. METHODS AND RESULTS: We applied the key eligibility criteria of 7 phase III HFpEF studies (Digitalis Investigation Group Ancillary, Candesartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction, Perindopril in Elderly People With Chronic Heart Failure, Irbesartan in Heart Failure With Preserved Systolic Function, Japanese Diastolic Heart Failure, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist, and Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF; ongoing]) to a typical and well-characterized HFpEF population (n = 557) seen in modern European cardiological practice...
April 18, 2017: Journal of Cardiac Failure
https://www.readbyqxmd.com/read/28379310/echocardiographic-predictors-of-atrial-fibrillation-in-patients-with-heart-failure-with-preserved-ejection-fraction
#15
Wesley T O'Neal, Pratik Sandesara, Nikhil Patel, Sanjay Venkatesh, Ayman Samman-Tahhan, Muhammad Hammadah, Heval M Kelli, Elsayed Z Soliman
Aims: To determine if markers of diastolic dysfunction are associated with atrial fibrillation (AF) development among patients with heart failure with preserved ejection fraction (HFpEF). Methods and Results: We examined the association of several echocardiographic measures of diastolic dysfunction with incident AF in 573 patients (mean age = 68 ± 9.5 years; 48% men; 79% white) with HFpEF from the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial (TOPCAT) who were free of baseline AF...
July 1, 2017: European Heart Journal Cardiovascular Imaging
https://www.readbyqxmd.com/read/28359411/interaction-between-spironolactone-and-natriuretic-peptides-in-patients-with-heart%C3%A2-failure-and-preserved-ejection%C3%A2-fraction-from-the-topcat-trial
#16
Inder S Anand, Brian Claggett, Jiankang Liu, Amil M Shah, Thomas S Rector, Sanjiv J Shah, Akshay S Desai, Eileen O'Meara, Jerome L Fleg, Marc A Pfeffer, Bertram Pitt, Scott D Solomon
OBJECTIVES: The aims of this study were to explore the relationship of baseline levels of natriuretic peptides (NPs) with outcomes and to test for an interaction between baseline levels of NPs and the effects spironolactone. BACKGROUND: Plasma NPs are considered to be helpful in the diagnosis of heart failure (HF) with preserved ejection fraction (HFpEF), and elevated levels are associated with adverse outcomes. Levels of NPs higher than certain cutoffs are often used as inclusion criteria in clinical trials of HFpEF to increase the likelihood that patients have HF and to select patients at higher risk for events...
April 2017: JACC. Heart Failure
https://www.readbyqxmd.com/read/28322009/prognostic-importance-of-left-ventricular-mechanical-dyssynchrony-in-heart-failure-with-preserved-ejection-fraction
#17
Tor Biering-Sørensen, Sanjiv J Shah, Inder Anand, Nancy Sweitzer, Brian Claggett, Li Liu, Bertram Pitt, Marc A Pfeffer, Scott D Solomon, Amil M Shah
AIMS: Left ventricular mechanical dyssynchrony has been described in heart failure with preserved ejection fraction (HFpEF), but its prognostic significance is not known. METHODS AND RESULTS: Of 3445 patients with HFpEF enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, dyssynchrony analysis was performed on 424 patients (12%) by multiple speckle tracking echocardiography strain-based criteria. The primary dyssynchrony analysis was the standard deviation of the time to peak longitudinal strain (SD T2P LS)...
August 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/27965882/trial-of-optimal-personalised-care-after-treatment-for-gynaecological-cancer-topcat-g-a-study-protocol-for-a-randomised-feasibility-trial
#18
Kirstie Pye, Nicola Totton, Nicholas Stuart, Rhiannon Whitaker, Val Morrison, Rhiannon Tudor Edwards, Seow Tien Yeo, Laura J Timmis, Caryl Butterworth, Liz Hall, Tekendra Rai, Zoe Hoare, Richard D Neal, Clare Wilkinson, Simon Leeson
BACKGROUND: Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years...
2016: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/27873428/data-and-safety-monitoring-board-evaluation-and-management-of-a-renal-adverse-event-signal-in-topcat
#19
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...
April 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/27753859/sp-01-3-aldosterone-antagonists-in-heart-failure
#20
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
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