Study of Verinurad in Heart Failure With Preserved Ejection Fraction

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure With Preserved Ejection Fraction (HFpEF)

In brief

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

Key facts

Study ID

NCT04327024

Run by

AstraZeneca

People needed

159

Starts

2020-05-19

Expected to finish

2022-04-29

Last updated by the study team

2023-06-29

Who can join

Age: 40 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Have NYHA functional class II-III at enrolment
• Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment
• LVEF ≥ 45%
• NT-proBNP ≥ 125 pg/mL (≥ 14.75 pmol/L) at Visit 1 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Northridge, California, United States
• Research Site — Torrance, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Norfolk, Virginia, United States
• Research Site — CABA, Argentina
• Research Site — CABA, Argentina
• Research Site — CABA, Argentina
• Research Site — Mar del Plata, Argentina
• Research Site — Mar del Plata, Argentina
• Research Site — Rosario, Argentina
• Research Site — Bedford Park, Australia
• Research Site — Chermside, Australia
• Research Site — Geelong, Australia
• Research Site — Milton, Australia
• Research Site — Graz, Austria
• Research Site — Vienna, Austria
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Québec, Quebec, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Granada Hills, California, United States

Full record on ClinicalTrials.gov

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