Previously submitted to: JMIR Research Protocols (no longer under consideration since Dec 02, 2024)
Date Submitted: May 18, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Assessing Hypotension Incidence and Dosing Strategies of Sacubitril/Valsartan in Real-World Heart Failure Management: Protocol for A Retrospective, Multicenter, Cohort Study
ABSTRACT
Background:
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 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.
Objective:
The primary aim of this study is to evaluate the incidence of hypotension among HFrEF patients receiving sacubitril/valsartan and assess the feasibility of dose titration to achieve optimal tolerated doses in real-world settings. Secondary objectives include evaluating treatment outcomes, tolerability, and factors influencing dosing adjustments.
Methods:
This is the protocol of a retrospective, multicenter cohort study aimed at assessing real-world usage patterns of sacubitril/valsartan among Indian HFrEF patients, focusing on hypotension occurrence and optimal dose attainment. 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 analyzed using appropriate statistical tests. Data from approximately 150 healthcare facilities will be collected using a structured Case Report Form (CRF).
Results:
The study was initiated in February 2024. As of manuscript submission, 892 individuals have been recruited, with data collection expected to conclude by the end of May and results anticipated by June.
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 Clinical Trial: Nil
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.