Study of Verinurad in Heart Failure With Preserved Ejection Fraction

• Status: Active, not recruiting
• Trial end date: 2022-11-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Allopurinol; Verinurad

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:

1. Have NYHA functional class II-III at enrolment

2. Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment

3. LVEF ≥ 45%

4. 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

Exclusion Criteria:

• eGFR < 30ml/min/1.73m2 (based on CKD-EPI formula)

• Presence of any condition that precludes exercise testing

• Known history of a documented LVEF < 40%

• Probable alternative or concomitant diagnoses which in the opinion of the Investigator could account for the patient's HF symptoms and signs (eg, anaemia, hypothyroidism)

• Known carrier of the Human Leukocyte Antigen-B (HLA-B) *58:01 allele: HLA-B

*58:01 genotyping is mandatory prior to randomization for all patients.

• Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome

• Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the patients' tasks associated with the protocol

• Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardises the quality of the data to be generated

• Current acute decompensated HF or hospitalisation due to decompensated HF < 4 weeks prior to enrolment

• Myocardial infarction, unstable angina, coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronisation therapy device, stroke or transient ischemic attack within 6 months prior to enrolment.

• Planned coronary revascularisation, ablation of atrial flutter/fibrillation and/or valve repair/replacement

• Atrial fibrillation with persistent resting heart rate > 110 beats per minute.