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

• 批准号: 10683332
• 负责人: DALANE W KITZMAN
• 金额: $ 701.02万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 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/10683332
• 关键词: Accident and Emergency department; Acute; Address; Affect; Age; Attention; Black Populations; Blood Banks; Blood specimen; Caregivers; Cessation of life; Clinic Visits; Clinical; Cognition; Congestive Heart Failure; 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; Home; 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; adjudication; attentional control; clinical care; clinical center; cost effectiveness; cost estimate; 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

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。然而，大多数 测试多种治疗 ADHF 的药物和策略的试验结果是中立的。在我们最近 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 患有 ADHF 的老年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 HF 患者相比，虚弱、HRQOL 和抑郁程度更高。他们似乎也获得了更大的 从干预中受益，在身体功能、虚弱、HRQOL 和 沮丧。 HFpEF 患者的再住院率和死亡率似乎也大幅减少 死亡和医疗资源使用减少的可能性。 HFpEF 潜在更大益处的发现是 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 妇女和黑人； 2）患病率增加； 3）被认为是一种老年综合症； 4）关联 身体机能和 HRQOL 明显受损，虚弱率高； 5）发病率高 死亡率随着时间的推移而恶化； 6) 循证治疗有限。第三阶段 REHAB- HFpEF 试验将重点关注这一庞大、不断增长、脆弱、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 分布在 20 个地理上分散的临床中心。我们将测试创新 REHAB-HF 的假设 干预将改善全因再住院的临床引人注目的综合主要终点 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、 体力活动和医疗保健费用。我们多元化、有凝聚力、多学科的团队和来自 第二阶段试验将确保高效、有效的执行和传播。 REHAB-HFpEF 直接寻址 最近 NIA 和 NHLBI 主办的几次研讨会的主要建议。其结果可能会有所改善 对患者、护理人员、卫生系统和付款人有意义的关键成果。审判具有很强的 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。

项目成果

Comparative effectiveness of pelvic floor muscle training, mirabegron, and trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.

• DOI: 10.1186/s40814-023-01440-w
• 发表时间: 2024-01-04
• 期刊: PILOT AND FEASIBILITY STUDIES
• 影响因子: 1.7
• 作者: Fisher, Steve R.;Villasante-Tezanos, Alejandro;Allen, Lindsay M.;Pappadis, Monique R.;Kilic, Gokhan
• 通讯作者: Kilic, Gokhan