TOPCAT

BACKGROUND: Black patients have been shown to have different baseline characteristics and outcomes compared with nonblack patients in cohort studies. However, few studies have focused on heart failure (HF) with preserved ejection fraction (HFpEF) patients. We aimed to determine the difference in cardiovascular outcomes in black and nonblack patients with HFpEF and to determine the relative efficacy and safety of spironolactone in black and nonblack patients. METHODS AND RESULTS: Patients with HFpEF, randomized to spironolactone versus placebo in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) in North and South America, were grouped according to self-described black and nonblack race...

BACKGROUND: It remains unknown whether a low diastolic blood pressure (DBP) increases the risks of cardiovascular events and death in patients with heart failure with preserved ejection fraction (HFpEF). METHODS: We used data from the TOPCAT trial. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure. Hazard ratios (HRs) were analyzed for DBPs of <60, 60-69, 70-79, and ≥90 mm Hg in comparison with a DBP of 80-89 mm Hg using multivariable Cox proportional hazard models...

BACKGROUND: In patients with heart failure and preserved ejection fraction (HF-PEF) randomized in the Americas (but not Russia and Georgia) as part of the TOPCAT trial, treatment with spironolactone enhanced the risk of hyperkalemia but reduced the risk of hypokalemia. We examined the clinical correlates and prognostic implications of incident hypo- and hyperkalemia during study follow up. METHODS: We defined the region-specific incidence of hypokalemia (potassium [K+ ]<3...

BACKGROUND: Sudden death (SD) may be an important mode of death in heart failure with preserved ejection fraction (HFpEF). OBJECTIVES: To investigate rates and predictors of SD or aborted cardiac arrest (ACA) in HFpEF. METHODS: We studied 1,767 patients with HFpEF (EF≥45%) enrolled in the Americas region of the TOPCAT trial. We identified independent predictors of composite SD/ACA with step-wise backward selection using competing risks regression analysis accounting for non-sudden causes of death...

BACKGROUND: Although diastolic blood pressure (DBP) is independently associated with an increased risk of adverse cardiovascular outcomes in the general population, it is unclear if a similar relationship exists in patients with heart failure with preserved ejection fraction. METHODS AND RESULTS: This analysis included 1703 (mean age, 72±10 years; 50% men; 78% white) patients with heart failure with preserved ejection fraction enrolled in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) Trial from the Americas who were treated for hypertension...

Left ventricular ejection fraction (EF) is a ratio that is deemed to accurately normalize stroke volume (SV) to end-diastolic volume (EDV). Ratios are now well-recognized for not normalizing the numerator, in this case SV, consistently for the denominator, EDV. We aimed to provide the first allometric-based scrutiny of the conventional assumptions that underpin the EF ratio. We allometrically modelled untransformed SV and EDV measurements from 112 preclinical heart failure patients in the Multi-Ethnic Study of Atherosclerosis (MESA), and 864 chronic heart failure patients in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study...

OBJECTIVE: This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment-Gynaecological. METHODS: The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals...

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 mm Hg on 3 or more medications, in the Americas cohort of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial, in which patients with HFpEF were randomized to spironolactone vs...

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...

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...

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...

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...

No abstract text is available yet for this article.

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...

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...

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...

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...

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)...

No abstract text is available yet for this article.

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...