Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

老年急性 HFpEF 患者的身体康复 - REHAB-HFpEF 试验

基本信息

批准号：
10501900
负责人：
DALANE W KITZMAN
金额：
$ 594.4万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10501900
关键词：
Accident and Emergency department Acute Address Affect Age Attention Black Populations Blood specimen Caregivers Cessation of life Clinic Visits Clinical Cognition Data Dissemination and Implementation EFRAC Educational workshop Elderly Enrollment Ensure Event Evidence based treatment Funding Future Geography Guidelines Health Care Costs Health system Heart failure Hospitalization Impairment Institutionalization Intervention Leadership Medical Medicare claim Mental Depression Morbidity - disease rate Multicenter Trials National Heart, Lung, and Blood Institute Not Hispanic or Latino Outcome Participant Pathway interactions Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Phenotype Physical Function Physical Performance Physical Rehabilitation Physical activity Prevalence Randomized Recommendation Reporting Research Personnel Resources Structure Subgroup Syndrome Testing Time Underserved Population Vulnerable Populations Walking Woman adjudicate attentional control clinical care clinical center cohesion cost effectiveness cost estimate data repository disability experience falls follow-up frailty health care service utilization health related quality of life heart preservation high risk high risk population hospital readmission improved innovation intervention effect intervention program meter mortality multidisciplinary novel older patient older women phase II trial physical conditioning physically handicapped preservation primary endpoint primary outcome response secondary endpoint secondary outcome single-blind trial treatment as usual trend

项目摘要

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%) with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB- HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression, physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers. The trial has strong potential to change clinical guidelines, reduce health care costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFpEF.

急性失代偿性心力衰竭（ADHF）是老年人住院的主要原因，与明显的身体残疾、健康相关的生活质量 (HRQOL) 差、频繁再住院、丧失独立性、高死亡率和巨额医疗费用。我们最近测试了多种治疗 ADHF 的药物和策略的试验结果是中立的。完成了 NIA 资助的 2 期试验 (REHAB-HF)，这是一项创新、早期、过渡、定制和渐进的试验多领域物理康复干预使 Short 的主要结局有了很大改善老年 ADHF 患者的身体表现电池（+1.5 分）在基线时，参与者 (53%)。射血分数保留的心力衰竭 (HFpEF) 的身体功能损伤明显更严重，与 EF 降低的心力衰竭患者相比，他们的虚弱、HRQOL 和抑郁程度似乎也更高。从干预中受益，在身体功能、虚弱、HRQOL 和 HFpEF 患者的再住院率和抑郁症似乎也明显减少。死亡和减少医疗资源使用的潜力发现 HFpEF 具有更大的潜在益处。值得注意的是，HFpEF 与老年人高度相关，并且最迫切需要新的治疗方法因为它是： 1) 最常见的心力衰竭形式，几乎是老年人所特有的，并且对老年人的影响尤为严重女性和黑人；2) 患病率增加；3) 被认为是一种老年综合症； 5) 身体机能和 HRQOL 明显受损，虚弱率高；死亡率随着时间的推移而恶化；6) 基于证据的治疗有限。 HFpEF 试验将重点关注这一庞大的、不断增长的、弱势的、服务不足的人群，为期 5 年、随机、注意力控制、单盲试验将招募 880 名年龄 > 60 岁患有 ADHF 和 HFpEF 的老年人我们将在 20 个地理上分散的临床中心测试创新 REHAB-HF 的假设。干预将改善全因再住院的临床综合引人注目的主要终点 6 个月随访期间的死亡率，即 ADHF 住院后最脆弱的时间段（目标 1）和次要终点是严重行动障碍的患病率，这是一项有临床意义的试验结果 6 个月大的老年人（目标 2）。我们还将评估干预措施对 HRQOL、虚弱、抑郁、我们拥有多元化、有凝聚力、多学科的团队和丰富的经验。第二阶段试验将确保 REHAB-HFpEF 的有效执行和传播。 NIA 和 NHLBI 最近主办的几次研讨会的主要建议可以改善其结果。对患者、护理人员、卫生系统和付款人有意义的关键结果该试验具有很强的说服力。改变临床指南、降低医疗保健成本并影响全国覆盖的潜力为数量庞大、不断增长、服务不足的高危老年急性 HFpEF 患者做出决策。