Endpoints in Heart Failure Drug Development
Heart failure (HF) is a major health problem worldwide. The development of effective drug and/or device therapy is crucial to mitigate the significant morbidity, mortality and healthcare costs associated with HF. The choice of endpoint in clinical trials has important practical and clinical implicat...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Radcliffe Medical Media
2022-01-01
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| Series: | Cardiac Failure Review |
| Online Access: | https://www.cfrjournal.com/articleindex/cfr.2021.13 |
| _version_ | 1797200041340829696 |
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| author | Aliza Hussain Arunima Misra Biykem Bozkurt |
| author_facet | Aliza Hussain Arunima Misra Biykem Bozkurt |
| author_sort | Aliza Hussain |
| collection | DOAJ |
| description | Heart failure (HF) is a major health problem worldwide. The development of effective drug and/or device therapy is crucial to mitigate the significant morbidity, mortality and healthcare costs associated with HF. The choice of endpoint in clinical trials has important practical and clinical implications. Outcomes of interest including mortality and HF hospitalisations provide robust evidence for regulatory approval granted there is sufficiency of safety data. At the same time, it is important to recognise that HF patients experience significant impairments in functional capacity and quality of life, underscoring the need to incorporate parameters of symptoms and patient-reported outcomes in clinical trials. In this review, the authors summarise the evolution and definition of cardiovascular endpoints used in clinical trials, discuss approaches to study design to allow the incorporation of mortality, morbidity and functional endpoints and, finally, examine the current challenges and suggest steps for the development of cardiovascular endpoints that are effective, meaningful and meet the needs of all relevant stakeholders, including patients, physicians regulators and sponsors. |
| first_indexed | 2024-03-07T17:39:52Z |
| format | Article |
| id | doaj.art-5010f6e2b046491a8cf765245cb0c126 |
| institution | Directory Open Access Journal |
| issn | 2057-7540 2057-7559 |
| language | English |
| last_indexed | 2024-04-24T07:25:20Z |
| publishDate | 2022-01-01 |
| publisher | Radcliffe Medical Media |
| record_format | Article |
| series | Cardiac Failure Review |
| spelling | doaj.art-5010f6e2b046491a8cf765245cb0c1262024-04-20T16:02:39ZengRadcliffe Medical MediaCardiac Failure Review2057-75402057-75592022-01-01810.15420/cfr.2021.13Endpoints in Heart Failure Drug DevelopmentAliza Hussain0Arunima Misra1Biykem Bozkurt2Winters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E DeBakey VA Medical Center, Houston, TX, USWinters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E DeBakey VA Medical Center, Houston, TX, USWinters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E DeBakey VA Medical Center, Houston, TX, US; Cardiovascular Research Institute, Baylor College of Medicine, Houston, TX, USHeart failure (HF) is a major health problem worldwide. The development of effective drug and/or device therapy is crucial to mitigate the significant morbidity, mortality and healthcare costs associated with HF. The choice of endpoint in clinical trials has important practical and clinical implications. Outcomes of interest including mortality and HF hospitalisations provide robust evidence for regulatory approval granted there is sufficiency of safety data. At the same time, it is important to recognise that HF patients experience significant impairments in functional capacity and quality of life, underscoring the need to incorporate parameters of symptoms and patient-reported outcomes in clinical trials. In this review, the authors summarise the evolution and definition of cardiovascular endpoints used in clinical trials, discuss approaches to study design to allow the incorporation of mortality, morbidity and functional endpoints and, finally, examine the current challenges and suggest steps for the development of cardiovascular endpoints that are effective, meaningful and meet the needs of all relevant stakeholders, including patients, physicians regulators and sponsors.https://www.cfrjournal.com/articleindex/cfr.2021.13 |
| spellingShingle | Aliza Hussain Arunima Misra Biykem Bozkurt Endpoints in Heart Failure Drug Development Cardiac Failure Review |
| title | Endpoints in Heart Failure Drug Development |
| title_full | Endpoints in Heart Failure Drug Development |
| title_fullStr | Endpoints in Heart Failure Drug Development |
| title_full_unstemmed | Endpoints in Heart Failure Drug Development |
| title_short | Endpoints in Heart Failure Drug Development |
| title_sort | endpoints in heart failure drug development |
| url | https://www.cfrjournal.com/articleindex/cfr.2021.13 |
| work_keys_str_mv | AT alizahussain endpointsinheartfailuredrugdevelopment AT arunimamisra endpointsinheartfailuredrugdevelopment AT biykembozkurt endpointsinheartfailuredrugdevelopment |