Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.
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ABSTRACT:
SUBMITTER: Paton MF
PROVIDER: S-EPMC6661620 | biostudies-literature | 2019 Jul
REPOSITORIES: biostudies-literature
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Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.
Paton Maria F MF Gierula John J Jamil Haqeel A HA Lowry Judith E JE Byrom Rowena R Gillott Richard G RG Chumun Hemant H Cubbon Richard M RM Cairns David A DA Stocken Deborah D DD Kearney Mark T MT Witte Klaus K KK
BMJ open 20190717 7
<h4>Introduction</h4>Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy.<h4>Methods and analysis</h4>The study is a multicentre, ph ...[more]
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Project description:BackgroundAccording to the current guidelines, implantable cardioverter-defibrillators (ICD) for primary prevention in patients with heart failure and reduced ejection fraction (HFrEF) should not be considered until optimal guideline-directed medical therapy (GDMT) has been achieved for a minimum of 3 months. Optimization of GDMT often needs time beyond 3 months after diagnosis. The aim of the Heart Failure Optimization Study (HF-OPT) is to evaluate the recovery of left ventricular function beyond 3 months after diagnosis of newly diagnosed HFrEF.MethodsThe HF-OPT multicenter study is comprised of two non-randomized phases (registry and study). During the first 90 days a wearable cardioverter-defibrillator (WCD) is prescribed and patients are enrolled in an observational pre-study registry. Registry subjects meeting inclusion criteria for the study portion at day 90 have ongoing left ventricular ejection fraction (LVEF) reassessment at 90, 180 and 360 days after the index hospital discharge, regardless of continued WCD use. Approximately 600 subjects will be enrolled in the study portion. Of those, one-third are anticipated to start the study phase at day 90 with reduced LVEF. The primary objective of this study is to observe the rate of recovery of LVEF > 35% between 90 and 180 days, while key secondary endpoints include mortality and WCD recorded arrhythmias and shocks.DiscussionThe HF-OPT study will provide important information on the rate of additional recovery of LVEF > 35%, between 90 and 180 days, in newly diagnosed HF with reduced LVEF patients being titrated with GDMT. The results of the study may impact indications for primary prophylactic ICD implantation.
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Project description:BackgroundTrial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments.MethodsIn our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094.FindingsWe recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p = 0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p = 0·0003), but did not differ for APT (0·7 [-0·9 to 2·3] points lower; p = 0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p = 0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p = 0·0005), but did not differ for APT (3·4 [-1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p = 0·0027; GET p = 0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group.InterpretationCBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.FundingUK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.
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Project description:INTRODUCTION:A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. METHODS AND ANALYSIS:This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease.The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant's care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge.The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. ETHICS AND DISSEMINATION:The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. TRIAL REGISTRATION NUMBER:ACTRN12616001627448.
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Project description:BACKGROUND:Guidelines recommend that patients with heart failure with reduced ejection fraction (HFrEF) have medical therapy titrated to target doses derived from clinical trials, as tolerated. The degree to which titration occurs in contemporary U.S. practice is unknown. OBJECTIVES:This study sought to characterize longitudinal titration of HFrEF medical therapy in clinical practice and to identify associated factors and reasons for medication changes. METHODS:Among 2,588 U.S. outpatients with chronic HFrEF in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry with complete medication data and no contraindications to medical therapy, use and dose of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB), angiotensin receptor-neprilysin inhibitor (ARNI), beta-blocker, and mineralocorticoid receptor antagonist (MRA) were examined at baseline and at 12-month follow-up. RESULTS:At baseline, 658 (25%), 525 (20%), 287 (11%), and 45 (2%) patients were receiving target doses of MRA, beta-blocker, ACEI/ARB, and ARNI therapy, respectively. At 12 months, proportions of patients with medication initiation or dose increase were 6% for MRA, 10% for beta-blocker, 7% for ACEI/ARB, and 10% for ARNI; corresponding proportions with discontinuation or dose decrease were 4%, 7%, 11%, and 3%, respectively. Over 12 months, <1% of patients were simultaneously treated with target doses of ACEI/ARB/ARNI, beta-blocker, and MRA. In multivariate analysis, across the classes of medications, multiple patient characteristics were associated with a higher likelihood of initiation or dose increase (e.g., previous HF hospitalization, higher blood pressure, lower ejection fraction) and discontinuation or dose decrease (e.g., previous HF hospitalization, impaired quality of life, more severe functional class). Medical reasons were the most common reasons for discontinuations and dose decreases of each therapy, but the relative contributions from patient preference, health team, and systems-based reasons varied by medication. CONCLUSIONS:In this contemporary U.S. registry, most eligible HFrEF patients did not receive target doses of medical therapy at any point during follow-up, and few patients had doses increased over time. Although most patients had no alterations in medical therapy, multiple clinical factors were independently associated with medication changes. Further quality improvement efforts are urgently needed to improve guideline-directed medication titration for HFrEF.
| S-EPMC7197490 | biostudies-literature
Project description:Heart failure continues to be one of the leading causes of morbidity and mortality worldwide. Myocardial infarction is the primary causative agent of chronic heart failure resulting in cardiomyocyte necrosis and the subsequent formation of fibrotic scar tissue. Current pharmacological and non-pharmacological therapies focus on managing symptoms of heart failure yet remain unable to reverse the underlying pathology. Heart transplantation usually cannot be relied on, as there is a major discrepancy between the availability of donors and recipients. As a result, heart failure carries a poor prognosis and high mortality rate. As the heart lacks significant endogenous regeneration potential, novel therapeutic approaches have incorporated the use of stem cells as a vehicle to treat heart failure as they possess the ability to self-renew and differentiate into multiple cell lineages and tissues. This review will discuss past, present, and future clinical trials, factors that influence stem cell therapy outcomes as well as ethical and safety considerations. Preclinical and clinical studies have shown a wide spectrum of outcomes when applying stem cells to improve cardiac function. This may reflect the infancy of clinical trials and the limited knowledge on the optimal cell type, dosing, route of administration, patient parameters and other important variables that contribute to successful stem cell therapy. Nonetheless, the field of stem cell therapeutics continues to advance at an unprecedented pace. We remain cautiously optimistic that stem cells will play a role in heart failure management in years to come.
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Project description:BackgroundDespite evidence that guideline-directed medical therapies (GDMTs) improve outcomes in patients with heart failure (HF) with reduced ejection fraction (HFrEF), implementation remains suboptimal.ObjectivesThe purpose of this study was to measure GDMT implementation during acute HFrEF hospitalization, evaluate the association between socioeconomic factors and GDMT implementation, and assess the association of GDMT utilization with subsequent clinical events.MethodsRetrospective determination of GDMT utilization using a modified optimal medical therapy (mOMT) score (which accounts for specific contraindications to drugs) during unplanned HF hospitalization of consecutive adult patients with new-onset or previously diagnosed HFrEF from 2017 to 2018. Outcomes included discharge mOMT score, association between socioeconomic factors and GDMT implementation (assessed using both the Mann-Whitney U test for binary variables and the Kruskall-Wallace for nonbinary variables), composite outcome 1-year all-cause mortality and 1-year HF readmission, and each component as a function of discharge mOMT score (assessed using univariate and multivariable Cox proportional hazards regression models).ResultsOf 391 patients fulfilling entry criteria (of which 152 [38.9%] had new-onset HFrEF), only 49 (12.5%) had a perfect or near-perfect discharge mOMT score. Black patients and those experiencing homelessness had significantly lower discharge mOMT scores. Higher discharge mOMT score is associated with a lower rate of composite endpoint events, particularly in patients with new-onset HFrEF. Overall, a 0.1-increase in the mOMT score resulted in a 9.2% reduction in the composite endpoint.ConclusionsSuboptimal implementation of GDMT during HF hospitalization is widespread and is associated with a worse outcome. Black patients and patients experiencing homelessness were less likely to have GDMT optimized.
| S-EPMC11312039 | biostudies-literature