Status:
COMPLETED
Study of Verinurad in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility:
All Genders
40-130 years
Phase:
PHASE2
Brief 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
Detailed Description
Evidence shows independent associations between hyperuricaemia and the risk of cardio-renal conditions, including heart failure (HF). Serum uric acid (sUA) is also a strong prognostic factor and corre...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2022
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT04327024
Start Date
May 19 2020
End Date
April 29 2022
Last Update
June 29 2023
Active Locations (58)
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1
Research Site
Granada Hills, California, United States, 91344
2
Research Site
Northridge, California, United States, 91324
3
Research Site
Torrance, California, United States, 90502
4
Research Site
Miami, Florida, United States, 33135