Effects of sacubitril/valsartan on hypertensive heart disease: the REVERSE-LVH randomized phase 2 trial

Vivian Lee, Mayank Dalakoti, Qishi Zheng, Desiree-Faye Toh, Redha Boubertakh, Jennifer A. Bryant, Tar-Choon Aw, Chi-Hang Lee, A. Mark Richards, Javed Butler, Javier Díez, Roger Foo, Stuart A. Cook, Carolyn SP Lam, Thu-Thao Le and Calvin WL Chin ()
Additional contact information
Vivian Lee: National Heart Centre Singapore
Mayank Dalakoti: National University Health System
Qishi Zheng: Cochrane Singapore
Desiree-Faye Toh: National Heart Centre Singapore
Redha Boubertakh: National Heart Centre Singapore
Jennifer A. Bryant: National Heart Centre Singapore
Tar-Choon Aw: Changi General Hospital
Chi-Hang Lee: National University Health System
A. Mark Richards: University of Otago
Javed Butler: Baylor Scott and White Research Institute
Javier Díez: University of Navarra
Roger Foo: National University Health System
Stuart A. Cook: National Heart Centre Singapore
Carolyn SP Lam: National Heart Centre Singapore
Thu-Thao Le: National Heart Centre Singapore
Calvin WL Chin: National Heart Centre Singapore

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract Diffuse interstitial fibrosis is associated with adverse outcomes in hypertensive heart disease and may be reversible. Sacubitril/valsartan could offer greater anti-fibrotic effects than valsartan alone. In the REVERSE-LVH phase 2 open-labelled trial (clinicaltrials.gov NCT: 03553810; funded by the National Medical Research Council of Singapore), 78 patients with essential hypertension and left ventricular hypertrophy (LVH) were randomized 1:1 to sacubitril/valsartan or valsartan for 52 weeks. Primary endpoint was a change in interstitial volume, assessed using cardiovascular magnetic resonance. Despite similar 24-hour systolic blood pressure at 52 weeks (125 ± 11 vs. 126 ± 11 mmHg; P = 0.762), sacubitril/valsartan resulted in a greater absolute reduction in interstitial volume compared to valsartan (−5.2 ± 5.4 vs. −2.5 ± 3.1 mL; P = 0.006). Secondary endpoints showed significant differences favoring sacubitril/valsartan in LV mass, left atrial volume, estimated LV filling pressure, and improved cardiac circulating biomarkers (N-terminal pro-B-type natriuretic peptide and high-sensitivity troponin T). Other markers of cardiac volumes, function and mechanics were similar between the two treatment arms. Here we show the potential myocardial benefits of sacubitril/valsartan beyond blood pressure control, though larger studies are needed to confirm their clinical relevance.

Date: 2025
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DOI: 10.1038/s41467-025-62203-0

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