Sodium-glucose cotransporter 2 inhibitors reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure and reduced ejection fraction (HFrEF). However, ...their effects on cardiac structure and function in HFrEF are uncertain.
We designed a multicenter, randomized, double-blind, placebo-controlled trial (the SUGAR-DM-HF trial Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus, or Prediabetes, and Heart Failure) to investigate the cardiac effects of empagliflozin in patients in New York Heart Association functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomly assigned 1:1 to empagliflozin 10 mg once daily or placebo, stratified by age (<65 and ≥65 years) and glycemic status (diabetes or prediabetes). The coprimary outcomes were change from baseline to 36 weeks in LV end-systolic volume indexed to body surface area and LV global longitudinal strain both measured using cardiovascular magnetic resonance. Secondary efficacy outcomes included other cardiovascular magnetic resonance measures (LV end-diastolic volume index, LV ejection fraction), diuretic intensification, symptoms (Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, B-lines on lung ultrasound, and biomarkers (including N-terminal pro-B-type natriuretic peptide).
From April 2018 to August 2019, 105 patients were randomly assigned: mean age 68.7 (SD, 11.1) years, 77 (73.3%) male, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LV ejection fraction 32.5% (9.8%), and 81 (77.1%) New York Heart Association II and 24 (22.9%) New York Heart Association III. Patients received standard treatment for HFrEF. In comparison with placebo, empagliflozin reduced LV end-systolic volume index by 6.0 (95% CI, -10.8 to -1.2) mL/m
(
=0.015). There was no difference in LV global longitudinal strain. Empagliflozin reduced LV end-diastolic volume index by 8.2 (95% CI, -13.7 to -2.6) mL/m
(
=0.0042) and reduced N-terminal pro-B-type natriuretic peptide by 28% (2%-47%),
=0.038. There were no between-group differences in other cardiovascular magnetic resonance measures, diuretic intensification, Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, or B-lines.
The sodium-glucose cotransporter 2 inhibitor empagliflozin reduced LV volumes in patients with HFrEF and type 2 diabetes or prediabetes. Favorable reverse LV remodeling may be a mechanism by which sodium-glucose cotransporter 2 inhibitors reduce heart failure hospitalization and mortality in HFrEF. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03485092.
Examination of patients with reduced and preserved ejection fraction in the DIG (Digitalis Investigation Group) trials and the CHARM (Candesartan in Heart Failure: Assessment of Reduction in ...Mortality and Morbidity) trials provides comparisons of outcomes in each of these types of heart failure. Comparison of the patients in these trials, along with the I-PRESERVE (Irbesartan in Heart Failure with Preserved Systolic Function Trial), with patients of similar age, sex distribution, and comorbidity in trials of hypertension, diabetes mellitus, angina pectoris, and atrial fibrillation provides even more interesting insights into the relation between phenotype and rates of death and heart failure hospitalization. The poor clinical outcomes in patients with heart failure and preserved ejection fraction do not seem easily explained on the basis of age, sex, comorbidity, blood pressure, or left ventricular structural remodeling but do seem to be explained by the presence of the syndrome of heart failure.
Hypertension control rates remain suboptimal. Pharmacists' scope of practice is evolving, and their position in the community may be ideal for improving hypertension care. We aimed to study the ...impact of pharmacist prescribing on blood pressure (BP) control in community-dwelling patients.
We designed a patient-level, randomized, controlled trial, enrolling adults with above-target BP (as defined by Canadian guidelines) through community pharmacies, hospitals, or primary care teams in 23 communities in Alberta. Intervention group patients received an assessment of BP and cardiovascular risk, education on hypertension, prescribing of antihypertensive medications, laboratory monitoring, and monthly follow-up visits for 6 months (all by their pharmacist). Control group patients received a wallet card for BP recording, written hypertension information, and usual care from their pharmacist and physician. Primary outcome was the change in systolic BP at 6 months. A total of 248 patients (mean age, 64 years; 49% male) were enrolled. Baseline mean±SD systolic/diastolic BP was 150±14/84±11 mm Hg. The intervention group had a mean±SE reduction in systolic BP at 6 months of 18.3±1.2 compared with 11.8±1.9 mm Hg in the control group, an adjusted difference of 6.6±1.9 mm Hg (P=0.0006). The adjusted odds of patients achieving BP targets was 2.32 (95% confidence interval, 1.17-4.15 in favor of the intervention).
Pharmacist prescribing for patients with hypertension resulted in a clinically important and statistically significant reduction in BP. Policy makers should consider an expanded role for pharmacists, including prescribing, to address the burden of hypertension.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00878566.
Aims
Pulmonary oedema is a common and important finding in acute heart failure (AHF). We conducted a systematic review to describe the methods used to assess pulmonary oedema in recent randomized AHF ...trials and report its prevalence in these trials.
Methods and results
Of 23 AHF trials published between 2002 and 2013, six were excluded because they were very small or not randomized, or missing full‐length publications. Of the remaining 17 (n = 200–7141) trials, six enrolled patients with HF and reduced ejection fraction (HF‐REF) and 11, patients with both HF‐REF and HF with preserved ejection fraction (HF‐PEF). Pulmonary oedema was an essential inclusion criterion, in most trials, based upon findings on physical examination (‘rales’), radiographic criteria (‘signs of congestion’), or both. The prevalence of pulmonary oedema in HF‐REF trials ranged from 75% to 83% and in combined HF‐REF and HF‐PEF trials from 51% to 100%. Five trials did not report the prevalence or extent of pulmonary oedema assessed by either clinical examination or chest x‐ray. Improvement of pulmonary congestion with treatment was inconsistently reported and commonly grouped with other signs of congestion into a score. One trial suggested that patients with rales over >2/3 of the lung fields on admission were at higher risk of adverse outcomes than those without.
Conclusion
Although pulmonary oedema is a common finding in AHF, represents a therapeutic target, and may be of prognostic importance, recent trials used inconsistent criteria to define it, and did not consistently report its severity at baseline or its response to treatment. Consistent and ideally quantitative, methods for the assessment of pulmonary oedema in AHF trials are needed.
Cardiac rhythm monitoring is performed to search for atrial fibrillation (AF) after ischaemic stroke or transient ischaemic attack (TIA). Prolonged cardiac rhythm monitoring increases AF detection ...but is challenging to implement in many healthcare settings and is not needed for all people after ischaemic stroke/TIA. We aimed to develop and validate a model that includes clinical, electrocardiogram (ECG), blood-based, and genetic biomarkers to identify people with a low probability of AF detection after ischaemic stroke or TIA. We will recruit 675 consenting participants who are aged over 18 years, who were admitted with ischaemic stroke or TIA in the 5 days prior, who are not known to have AF, and who would be suitable for anticoagulation if AF is found. We will collect baseline demographic and clinical data, a 12-lead ECG, and a venous blood sample for blood biomarkers (including midregional pro-atrial natriuretic peptide, MRproANP) and genetic data. We will perform up to 28 days of cardiac rhythm monitoring using an R-test or patch device to search for AF in all participants. The sample size of 675 participants is based on true sensitivity of 92.5%, null hypothesis sensitivity of 80%, 80% power, and 5% significance. The primary outcome is AF detection ≥30 s duration during 28 days of cardiac rhythm monitoring. Secondary outcomes are AF detection at 1-year, recurrent cardiovascular events, and mortality and will be identified by electronic linkage and telephone follow-up. The results will guide the development of a more personalized care pathway to search for AF after ischaemic stroke or TIA. This could help to reduce cardiac rhythm monitoring for people with a low probability of AF detection and allow more intensive cardiac monitoring to be focused on people who are more likely to have AF and benefit. Participants will be consented for their data to be used in future research studies, providing a rich resource for stroke and cardiovascular research communities.
Refocusing on hypertension control in Canada Leung, Alexander A; Bell, Alan; Tsuyuki, Ross T ...
Canadian Medical Association journal (CMAJ),
06/2021, Letnik:
193, Številka:
23
Journal Article
Recenzirano
Odprti dostop
Canada has been an international leader in hypertension care, but this appears to be changing. After more than 60 years of declining rates of cardiovascular death, trends are now reversing, along ...with reduced rates of detection, treatment and control of hypertension. According to a survey conducted in 2007-2009, 82% of Canadians with hypertension were treated and 69% were controlled; by comparison, survey data from 2016-17 showed that only 72% of affected adults were treated and a mere 58% were adequately controlled. In the most recent cycle of a national survey, fewer than two-thirds of women reported being treated for hypertension and fewer than half were controlled for hypertension. Here, Leung et al suggest several plausible explanations, including the loss of federal government support for hypertension surveillance, waning emphasis on implementation and evaluation of hypertension guidelines and termination of industry sponsorship for education initiatives as generic medications became more widely used.
Guidelines for the management of chronic heart failure (CHF) cite the results of randomized controlled trials (RCTs) to support treatment recommendations. The significance of an observed ...treatment-effect relies on the use of a boundary P-value, most commonly P < 0.05. There is concern about relying on arbitrary threshold P-values to report results as 'statistically significant'. The 'fragility index' (FI) has been proposed as an additional measure of the robustness of trial findings. FI is the minimum number of events needing to change from a non-event to an event in order to render a significant result non-significant. We calculated the FI to examine the robustness of statistically significant RCTs in CHF.
Two reviewers extracted data from RCTs supporting treatment recommendations in CHF guidelines. Twenty-five eligible trials were identified with a median sample size of 2331 patients (range 129-8399) and a median number of primary endpoints of 688.5 (range 88-2031). For the primary endpoint (analysed for 20 trials), the median FI was 26 (range 0-118). The FI was ≤10 in 7 (35%) of these 20 trials, and in 4 (20%) trials the number of patients lost to follow-up in the treatment group exceeded the FI.
The results of some large RCTs in CHF hinge on a small number of events. The FI offers an additional, easy to understand metric, which augments the standard reporting of boundary P-values for statistical significance. The FI helps in the interpretation of the robustness of the results of RCTs.
Globally, cardiovascular diseases (CVDs) are the leading cause of death. Viewed as a threat to the global economy, the United Nations included reducing noncommunicable diseases, including CVDs, in ...the 2030 sustainable development goals, and the World Health Assembly agreed to a target to reduce noncommunicable diseases 25% by the year 2025. In response, the World Health Organisation led the development of HEARTS, a technical package to guide governments in strengthening primary care to reduce CVDs. HEARTS recommends a public health and health system approach to introduce highly simplified interventions done systematically at a primary health care level and has a focus on hypertension as a clinical entry point. The HEARTS modules include healthy lifestyle counselling, evidence-based treatment protocols, access to essential medicines and technology, CVD risk-based management, team-based care, systems for monitoring, and an implementation guide. There are early positive global experiences in implementing HEARTS. Led by the Pan American Health Organisation, many national governments in the Americas are adopting HEARTS and have shown early success. Unfortunately, in Canada hypertension control is declining in women since 2010-2011 and the dramatic reductions in rates of CVD seen before 2010 have flattened when age adjusted and increased for rates that are not age adjusted, and there are marked increases in absolute numbers of Canadians with adverse CVD outcomes. Several steps that Canada could take to enhance hypertension control are outlined, the core of which is to implement a strong governmental nongovernmental collaborative strategy to prevent and control CVDs, focusing on HEARTS.
Principale cause de décès dans le monde, les maladies cardiovasculaires (MCV) sont considérées comme une menace pour l’économie mondiale; l’Organisation des Nations Unies a inclus la réduction des maladies non transmissibles, y compris les MCV, dans ses objectifs de développement durable à atteindre d’ici 2030, et l’Assemblée mondiale de la Santé a adopté une cible de réduction de 25 % des maladies non transmissibles d’ici 2025. Ces décisions ont incité l'Organisation mondiale de la Santé à mettre au point le guide technique HEARTS, qui vise à aider les gouvernements à améliorer les soins primaires afin de réduire les MCV. Le guide technique HEARTS recommande l’adoption d’une approche de santé publique et de systèmes de santé axés sur la mise en place d’interventions hautement simplifiées en contexte de soins de santé primaires, et désigne l’hypertension comme un point d’entrée clinique. Les modules du guide HEARTS portent notamment sur les services de counseling relatifs à l’adoption d’un mode de vie sain, la mise en œuvre de protocoles thérapeutiques reposant sur des données factuelles, l’accès aux médicaments essentiels et aux technologies de santé de base, la prise en charge des risques de MCV, et le recours à des équipes de soins et la mise en place de systèmes de suivi; ils comprennent également un guide de mise en œuvre. Les premiers résultats de la mise en œuvre du guide HEARTS sont positifs. Sous la direction de l’Organisation panaméricaine de la Santé, bon nombre d’administrations publiques nationales du continent américain ont adopté le guide HEARTS et en constatent déjà les avantages. Malheureusement, la maîtrise de l’hypertension chez les femmes a diminué au Canada depuis 2010-2011. En effet, les réductions spectaculaires des taux de MCV observés avant 2010 atteignent un plateau lorsqu’ils sont corrigés pour tenir compte de l’âge, et augmentent si on ne tient pas compte de l’âge. On note aussi des hausses marquées du nombre absolu de Canadiens chez qui les issues des MCV sont défavorables. Nous présentons plusieurs mesures que le Canada pourrait prendre pour améliorer la maîtrise de l’hypertension, la principale étant d’adopter une solide stratégie de collaboration entre organismes gouvernementaux et non gouvernementaux axée sur le guide HEARTS afin de prévenir et de maîtriser les MCV.
PDF
