Dhawan R, Mittal R, Kumar A, Laller KS, Gill PS, Rag A, Mittal N. Sacubitril/valsartan as add-on to standard therapy in patients with heart failure: A randomized controlled trial. World J Exp Med 2025; 15(4): 111542 [PMID: 41497676 DOI: 10.5493/wjem.v15.i4.111542]
Corresponding Author of This Article
Niti Mittal, Associate Professor, DM, Department of Pharmacology, PGIMS, Rohtak 124001, Haryana, India. drnitimittal@uhsr.ac.in
Research Domain of This Article
Cardiac & Cardiovascular Systems
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Randomized Controlled Trial
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Dec 20, 2025 (publication date) through May 16, 2026
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Publication Name
World Journal of Experimental Medicine
ISSN
2220-315x
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Dhawan R, Mittal R, Kumar A, Laller KS, Gill PS, Rag A, Mittal N. Sacubitril/valsartan as add-on to standard therapy in patients with heart failure: A randomized controlled trial. World J Exp Med 2025; 15(4): 111542 [PMID: 41497676 DOI: 10.5493/wjem.v15.i4.111542]
World J Exp Med. Dec 20, 2025; 15(4): 111542 Published online Dec 20, 2025. doi: 10.5493/wjem.v15.i4.111542
Sacubitril/valsartan as add-on to standard therapy in patients with heart failure: A randomized controlled trial
Niti Mittal, Adarsh Rag, Paramjeet S Gill, Kuldip S Laller, Ashwani Kumar, Rakesh Mittal, Reevanshi Dhawan
Reevanshi Dhawan, Rakesh Mittal, Adarsh Rag, Niti Mittal, Department of Pharmacology, PGIMS, Rohtak 124001, Haryana, India
Ashwani Kumar, Kuldip S Laller, Department of Cardiology, PGIMS, Rohtak 124001, Haryana, India
Paramjeet S Gill, Department of Microbiology, PGIMS, Rohtak 124001, Haryana, India
Co-first authors: Reevanshi Dhawan and Rakesh Mittal.
Author contributions: Dhawan R, Mittal R, Kumar A, Laller KS, Gill PS, Rag A, and Mittal N performed the conceptualization, data curation, data analysis, manuscript writing, and revision of the manuscript; the designation of two co-first authors is justified based on their equal and significant contributions to the conceptualization, execution, and communication of this study; all authors have played pivotal roles in guiding the research, analyzing data, and ensuring the manuscript's accuracy and completeness.
Institutional review board statement: This study was reviewed and approved by the Biomedical Research Ethics Committee of PGIMS, Rohtak, Haryana, No. BREC/23/TH-Pharma/01.
Clinical trial registration statement: The trial was registered prospectively with the clinical trials registry of India, No. CTRI/2023/07/055325.
Informed consent statement: All patients who participated in this study provided written informed consent.
Conflict-of-interest statement: All authors declare that they have no conflicts of interest to disclose.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Corresponding author: Niti Mittal, Associate Professor, DM, Department of Pharmacology, PGIMS, Rohtak 124001, Haryana, India. drnitimittal@uhsr.ac.in
Received: July 3, 2025 Revised: July 23, 2025 Accepted: October 27, 2025 Published online: December 20, 2025 Processing time: 170 Days and 1.5 Hours
Core Tip
Core Tip: This randomized clinical trial evaluated the efficacy and safety of sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor, as add-on to standard therapy compared to standard therapy alone in patients with New York Heart Association functional class II-III heart failure (HF). A total of 80 patients were enrolled out of which 25 patients in each group were available for per-protocol analysis. Baseline demographic, clinical and biochemical characteristics in both the groups were comparable. Sacubitril/valsartan demonstrated significant improvements in HF biomarkers, inflammation, and quality of life after 12 weeks without compromising safety supporting its role as an effective addition to standard HF therapy.
