Assessing hypotension incidence and dosing strategies of sacubitril/valsartan in real-world heart failure management: protocol for a retrospective, multicentre and cohort study

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dc.contributor.authorJadhav, UMen_US
dc.contributor.authorShah, Jen_US
dc.contributor.authorMohanty, Aen_US
dc.contributor.authorChenniappan, Men_US
dc.contributor.authorSattur, AGen_US
dc.contributor.authorMukhopadhyay, Men_US
dc.contributor.authorKrishna, KNen_US
dc.contributor.authorRaikar, Men_US
dc.contributor.authorMahale, SBen_US
dc.contributor.authorMajumdar, Den_US
dc.contributor.authorShaila, Sen_US
dc.contributor.authorPrakash, Gen_US
dc.contributor.authorHirapur, ISen_US
dc.contributor.authorAbdali, Nen_US
dc.contributor.authorSurwade, Hen_US
dc.contributor.authorAbid, MTKen_US
dc.contributor.authorThakran, Ven_US
dc.contributor.authorSharma, Aen_US
dc.contributor.authorMahajan, N.en_US
dc.date.accessioned2025-05-09T08:46:58Z
dc.date.available2025-05-09T08:46:58Z
dc.date.issued2024-09
dc.description.abstractBackground: The burden of heart failure (HF) and hypertension in India underscores the need for effective management strategies. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor (ARNi), has emerged as a pivotal therapy for HF with reduced ejection fraction (HFrEF). However, concerns about hypotension often hinder optimal dosing in clinical practice. The primary objective of this study is to observe the incidence of hypotension in HFrEF patients and to evaluate the best clinical practice to achieve an optimal tolerated dose of sacubitril/valsartan without treatment discontinuation. Secondary objectives include evaluating treatment outcomes, tolerability, and factors influencing dosing adjustments. Methods: This is the protocol of a retrospective, multicentre cohort study aimed at assessing real-world usage patterns of sacubitril/valsartan among Indian HFrEF patients. Patients aged 18-80 years diagnosed with HFrEF (left ventricular ejection fraction (LVEF) ?40%) and initiated on sacubitril/valsartan between November 2023 and May 2024 will be included. Baseline and follow-up data, including demographics, medical history, and treatment outcomes, will be analysed using appropriate statistical tests. Data from approximately 150 healthcare facilities will be collected using a structured case report form (CRF). The study was initiated in February 2024. As of manuscript submission, 1039 individuals have been enrolled on the study. Data collection is expected to continue until the end of June 2024. Conclusions: This study aims to contribute valuable insights into optimizing sacubitril/valsartan therapy for HFrEF patients in India, addressing concerns about hypotension and dosage optimization. The study seeks to inform clinical practice and enhance patient care by elucidating real-world usage patterns and outcomes.en_US
dc.identifier.affiliationsDepartment of Cardiology and Cardiac CT, MGM New Bombay Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology and Angiology, Krish Heart Care, Ahmedabad, Gujarat, Indiaen_US
dc.identifier.affiliationsDepartment of Intra Vascular Imaging, Sir Ganga Ram Hospital, New Delhi, Delhi, Indiaen_US
dc.identifier.affiliationsDepartment of Cardiology, Ramakrishna Medical Centre LLP (Heart Care Unit) Trichy, Tamil Nadu, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Sattur Heart Care, Hubli, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Amri Hospital, Salt Lake, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Aditya Health Clinics, Hyderabad, Telangana, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Aster CMI Hospital, Bengaluru, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Sanjivini Hospital, Virar, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, R.N. Tagore Hospital, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Kalinga Hospital, Bhubaneswar, Odisha, Indiaen_US
dc.identifier.affiliationsDepartment of Cardiology, Apollo Spectra Hospital, Patna, Bihar, Indiaen_US
dc.identifier.affiliationsDepartment of Cardiology, Gulbarga Heart Foundation, Kalaburagi, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Cardiology, Mahavir Vatsalya, Patna, Bihar, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Platinum Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Fairmed Clinic, Meerut, Uttar Pradesh, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, BLK Max Heart Centre, Delhi, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Cardiac Unit, MLBMC, Jhansi, Uttar Pradesh, Indiaen_US
dc.identifier.affiliationsDepartment of Interventional Cardiology, Tagore Hospital and Heart Centre, Jalandhar, Punjab, Indiaen_US
dc.identifier.citationJadhav UM, Shah J, Mohanty A, Chenniappan M, Sattur AG, Mukhopadhyay M, Krishna KN, Raikar M, Mahale SB, Majumdar D, Shaila S, Prakash G, Hirapur IS, Abdali N, Surwade H, Abid MTK, Thakran V, Sharma A, Mahajan N.. Assessing hypotension incidence and dosing strategies of sacubitril/valsartan in real-world heart failure management: protocol for a retrospective, multicentre and cohort study . International Journal of Clinical Trials. 2024 Sep; 11(3): 215-219en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/243663
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber3en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20241617en_US
dc.subjectSacubitril/valsartanen_US
dc.subjectHeart Failureen_US
dc.subjectReduced ejection fractionen_US
dc.subjectReal-world evidenceen_US
dc.subjectBlood pressureen_US
dc.subjectTolerabilityen_US
dc.subjectEffectivenessen_US
dc.titleAssessing hypotension incidence and dosing strategies of sacubitril/valsartan in real-world heart failure management: protocol for a retrospective, multicentre and cohort studyen_US
dc.typeJournal Articleen_US
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