Study of verinurad and allopurinol in heart failure with preserved ejection fraction

A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction - AMETHYST

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004862-16-DE

Enrollment

150

Registered

2020-03-09

Start date

2020-06-03

Completion date

Unknown

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure Patients with Preserved Ejection Fraction (HFpEF) and hyperuricaemia MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved ejection fraction System Organ Class: 100000004849

Interventions

Product Name: Verinurad Product Code: RDEA3170 Pharmaceutical Form: Prolonged-release capsule, hard INN or Proposed INN: Verinurad CAS Number: 1352792-74-5 Current Sponsor code: AZ13665615 Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient must be = 40 years of age at the time of signing the ICF - Patients with hyperuricaemia defined as sUA level of > 6 mg/dL. - Patients with documented diagnosis of symptomatic HFpEF according to all of the following criteria: (a) Have NYHA functional class II-III at enrolment (b) Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment (c) LVEF = 45% (d) NT-proBNP = 125 pg/mL (= 14.75 pmol/L) at Visit 2 for patients without ongoing atrial fibrillation/flutter. - Patients able to exercise to near exhaustion during a CPET as exhibited by RER = 1.05 during CPET conducted during screening. If patient does not achieve RER = 1.05 the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomisation) after the initial test; in such cases the second test will serve as baseline. - Male or female Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105

Exclusion criteria

Exclusion criteria: - eGFR 110 beats per minute.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess effect of verinurad + allopurinol compared to placebo on exercise capacity;Secondary Objective: 1. To assess effect of verinurad + allopurinol compared to allopurinol monotherapy on exercise capacity 2. To assess effect of verinurad + allopurinol compared to placebo and compared to allopurinol monotherapy on KCCQ-TSS;Primary end point(s): Change from baseline at Week 32 in peak VO2;Timepoint(s) of evaluation of this end point: At baseline and at week 32	—

Measure

Time frame

Main Objective: To assess effect of verinurad + allopurinol compared to placebo on exercise capacity;Secondary Objective: 1. To assess effect of verinurad + allopurinol compared to allopurinol monotherapy on exercise capacity 2. To assess effect of verinurad + allopurinol compared to placebo and compared to allopurinol monotherapy on KCCQ-TSS;Primary end point(s): Change from baseline at Week 32 in peak VO2;Timepoint(s) of evaluation of this end point: At baseline and at week 32

—

Secondary

Measure	Time frame
Secondary end point(s): Change from baseline at Week 32 in KCCQ-TSS;Timepoint(s) of evaluation of this end point: At baseline and at week 32	—

Countries

Argentina, Australia, Austria, Bulgaria, Canada, Germany, Korea, Republic of, Mexico, Poland, Russian Federation, Slovakia, United States

Contacts

Public ContactInformation Center

AstraZeneca

information.center@astrazeneca.com+1 (800) 236-9933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026