Heart Failure Polypill in India: A Late-Stage Implementation Strategy

印度的心力衰竭复方药物：后期实施策略

基本信息

批准号：
10924437
负责人：
ANUBHA AGARWAL
金额：
$ 5.4万
依托单位：
WASHINGTON UNIVERSITY
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：
2022-09-23 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10924437
关键词：
Adherence Adopted Adrenergic beta-Antagonists Adult Adverse event Age Angiotensin Receptor Area Australia Cardiomyopathies Cardiovascular Diseases Cardiovascular system Caring Chronic Chronic Disease Cities Clinical Clinical Trials Clinical Trials Design Collaborations Consensus Consolidated Framework for Implementation Research Country Data Collection Developing Countries Development Disease Disease Marker Disparate EFRAC Eligibility Determination Ensure Evaluation Focus Groups Funding Future Global Change Goals Guidelines HIV Health Personnel Heart Heart failure Hospitalization Hospitals Hybrids Hypertension Income India Individual Interruption Intervention Investments Kansas Left Ventricular Ejection Fraction Measures Medical Mentorship Methodology Methods Mineralocorticoid Receptor Morbidity - disease rate National Heart, Lung, and Blood Institute Natriuretic Peptides New York Outcome Participant Patient Care Patients Pharmaceutical Preparations Pharmacotherapy Phase Positioning Attribute Prevalence Process Public Health Questionnaires Reach, Effectiveness, Adoption, Implementation, and Maintenance Registries Reporting Research Research Methodology Risk Factors Safety Science Series Serious Adverse Event Severity of illness Strategic vision Target Populations Time Titrations Training Training Activity Translating Treatment Failure United States United States National Institutes of Health Universities Withdrawal antagonist burden of illness career design disorder control evidence base global health health related quality of life implementation barriers implementation evaluation implementation outcomes implementation science implementation strategy improved innovation low and middle-income countries medication compliance meetings mortality multidisciplinary novel novel strategies pharmacologic primary outcome process evaluation randomized, clinical trials research and development secondary outcome sex socioeconomics success treatment as usual trial design

项目摘要

PROJECT SUMMARY/ABSTRACT Heart failure (HF) is a leading global public health problem. The burden of HF is increasing in low- and middle- income countries and clinical outcomes remain poor. Guideline-directed medical therapy (a combination of distinct medications from disparate drug classes) improves morbidity and mortality in patients with HF with reduced ejection fraction (HFrEF). Despite this high-quality evidence, guideline-directed medical therapy remains widely underutilized globally and specifically in India. This gap represents a key target for intervention to save lives. Dr. Agarwal’s K99/R00 proposal aims to substantially simplify HF management by shifting the treatment paradigm for undertreated patients with HFrEF from multi-drug therapy with sequential initiation and titration to a novel late-stage implementation strategy of a HFrEF polypill of guideline-directed medical therapy including a beta-blocker, angiotensin receptor blocker, and mineralocorticoid receptor antagonist. First, Dr. Agarwal will conduct formative mixed methods research including a HF treatment consensus meeting and focus group discussions to guide development of the HFrEF polypill-based strategy in India. Second, she will evaluate whether, compared to usual care, a HFrEF polypill implementation strategy will reduce cardiovascular disease mortality and HF hospitalizations at 12 months in adults with HFrEF in India using a multi-center, type I hybrid randomized clinical trial design. She will also assess the effect of the HFrEF polypill implementation strategy on important secondary outcomes including medication adherence, markers of HF disease severity, health-related quality of life, and safety measured by adverse events. Finally, Dr. Agarwal will apply methods of process evaluation to assess implementation outcomes of the HFrEF polypill in India, a key step in translating evidence generated into broader use globally. The K99 phase will also provide essential methodological training for Dr. Agarwal to transition to research independence in the R00 phase. Dr. Agarwal proposes training in 1) implementation science methods, 2) clinical trial methods including innovative platform trial designs, and 3) regulatory science for global pharmacological clinical trials. This K99 training will prepare her to be a leading clinical trialist in global heart failure implementation science. Dr. Agarwal’s global mentorship team is led by Dr. Mark Huffman (Northwestern University, US), with key co-mentorship provided by experts in cardiovascular clinical trials in low- and middle-income countries, Drs. Dorairaj Prabhakaran (Centre for Chronic Disease Control, India) and Anushka Patel (The George Institute for Global Health, Australia). This mentorship team, supported by key collaborators (Drs. Hirschhorn, Mohanan, Ciolino) and advisors (Drs. Yancy, Lloyd-Jones), will ensure scientific success and oversee the candidate’s advanced training in their relative areas of expertise. This K99/R00 proposal supports Dr. Agarwal’s transition to launch an independent career as a future leader in global, late-stage translational cardiovascular research. Importantly, this proposal has the potential to transform HF care through simplified care in India and other settings, including in the United States.

项目概要/摘要心力衰竭（HF）是一个主要的全球公共卫生问题，中低收入人群的心力衰竭负担正在增加。收入国家和临床结果仍然不佳。不同药物类别的不同药物）可改善心力衰竭患者的发病率和死亡率尽管有这些高质量的证据，但仍需遵循指南指导的药物治疗。在全球范围内，特别是在印度，这一差距仍然广泛未被充分利用，这是干预的一个关键目标。 Agarwal 博士的 K99/R00 提案旨在通过改变心力衰竭管理方式来大幅简化心力衰竭管理。多药治疗中治疗不足的 HFrEF 患者的治疗范式指南指导药物治疗的 HFrEF 复方丸的新型后期实施策略的滴定包括β受体阻滞剂、血管紧张素受体阻滞剂和盐皮质激素受体拮抗剂。阿加瓦尔将进行形成性混合方法研究，包括心力衰竭治疗共识会议和其次，她将就印度 HFrEF 多药丸战略的发展指南进行焦点小组讨论。评估与常规护理相比，HFrEF 复方丸实施策略是否会减少心血管疾病使用多中心 I 型研究对印度成人 HFrEF 患者 12 个月时的疾病死亡率和 HF 住院情况进行评估她还将评估 HFrEF 多药丸实施的效果。重要次要结果的策略，包括药物依从性、心力衰竭疾病严重程度的标志物、最后，阿加瓦尔博士将应用以下方法：过程评估，以评估 HFrEF 复方药丸在印度实施的结果，这是转化的关键一步 K99 阶段还将提供必要的方法论。对 Agarwal 博士进行培训，以过渡到 R00 阶段的研究独立性。 Agarwal 博士建议进行培训。 1) 科学实施方法，2) 临床试验方法，包括创新平台试验设计，以及 3) 全球药理学临床试验的监管科学。K99 培训将使她成为一名领先的人。 Agarwal 博士的全球指导团队由全球心力衰竭实施科学临床试验专家领导。 Mark Huffman（美国西北大学），由心血管专家提供重要共同指导低收入和中等收入国家的临床试验，Dorairaj Prabhakaran 博士（慢性病中心） Control，印度）和 Anushka Patel（澳大利亚乔治全球健康研究所）这个导师团队，得到主要合作者（Hirschhorn 博士、Mohanan 博士、Ciolino 博士）和顾问（Yancy 博士、Lloyd-Jones 博士）的支持，将确保科学成功并监督候选人在其相关专业领域的高级培训。这项 K99/R00 提案支持 Agarwal 博士作为未来领导者开启独立职业生涯全球后期转化心血管研究重要的是，该提案有潜力。在印度和其他国家（包括美国），通过简化护理来转变心力衰竭护理。

项目成果

期刊论文数量（5）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Polypill Eligibility for Patients with Heart Failure with Reduced Ejection Fraction in the ASIAN-HF Registry: A Cross-Sectional Analysis.

ASIAN-HF 登记中射血分数降低的心力衰竭患者的多效避孕药资格：横断面分析。

DOI：
发表时间：
2023
期刊：
影响因子：
3.7
作者：
Vijay, Aishwarya;Tay, Wan Ting;Teng, Tiew;Teramoto, Kanako;Tromp, Jasper;Ouwerkerk, Wouter;Lo, Seet Yoong;Shimizu, Wataru;Huffman, Mark D;Lam, Carolyn S P;Chandramouli, Chanchal;Agarwal, Anubha
通讯作者：
Agarwal, Anubha

Frontiers of cardiovascular polypills: From atherosclerosis and beyond.

心血管多药丸的前沿：来自动脉粥样硬化及其他。

DOI：
发表时间：
2023-04
期刊：
影响因子：
9.3
作者：
Gnanenthiran, Sonali R;Agarwal, Anubha;Patel, Anushka
通讯作者：
Patel, Anushka

Toward a Universal Definition of Etiologies in Heart Failure: Categorizing Causes and Advancing Registry Science.

心力衰竭病因的普遍定义：病因分类和推进登记科学。

DOI：
发表时间：
2024-04
期刊：
影响因子：
0
作者：
Agarwal, Anubha;Tromp, Jasper;Almahmeed, Wael;Angermann, Christiane;Chandramouli, Chanchal;Cho, Hyunjai;Choi, Don;Damasceno, Albertino;Filippatos, Gerasimos;Fonarow, Gregg C;Harikrishnan, Sivadasanpillai;Lund, Lars;Masoudi, Fred;Mensah, Ge
通讯作者：
Mensah, Ge

Inclusion of Polypills for Prevention of Cardiovascular Disease in the 23rd World Health Organization Model List of Essential Medicines: A Significant Step Towards Reducing Global Cardiovascular Morbidity and Mortality.

将预防心血管疾病的复方药纳入第 23 版世界卫生组织基本药物标准清单：降低全球心血管发病率和死亡率的重要一步。

DOI：
发表时间：
2024
期刊：
影响因子：
3.7
作者：
Agarwal, Anubha;Huffman, Mark D
通讯作者：
Huffman, Mark D

Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular disease.

用于预防动脉粥样硬化性心血管疾病的固定剂量联合疗法。

DOI：
发表时间：
2024-04
期刊：
影响因子：
82.9
作者：
Agarwal, Anubha;Mehta, Priya M;Jacobson, Tyler;Shah, Nilay S;Ye, Jiancheng;Zhu, JingJing;Wafford, Q Eileen;Bahiru, Ehete;de Cates, Angharad N;Ebrahim, Shah;Prabhakaran, Dorairaj;Rodgers, Anthony;Huffman, Mark D
通讯作者：
Huffman, Mark D