Study of Verinurad in Heart Failure With Preserved Ejection Fraction

Phase 2 Completed 159 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction

Timeline

Start: 2020-05-19
Primary completion: 2022-04-29
Completion: 2022-04-29

Outcome

Missed primary endpoint

registry analysis (other test); Verinurad + Allopurinol vs Placebo; p = 0.862; Mean Difference (Final Values) -0.10 (95% CI -1.28 to 1.08); ANCOVA NCT04327024 ↗

registry Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue. NCT04327024 ↗

paper verinurad plus allopurinol did not result in a significant improvement in peak VO2 or symptoms compared with allopurinol monotherapy or placebo in HFpEF. PMID 39141378 ↗

Publications

Kitzman DW, Voors AA, Mentz RJ, Lewis GD, Perl S, Myte R, Kaguthi G, Sjostrom CD, Kallgren C, Shah SJ. Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: The AMETHYST Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):892-900. doi: 10.1001/jamacardio.2024.2435.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allopurinol	Small molecule	300 mg	Oral
Subject	Verinurad	Small molecule	12 mg	Oral