Phase 2
N=159
Study of Verinurad in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction (HFpEF)
Bottom Line
View on ClinicalTrials.gov: NCT04327024 ↗Enrolled (actual)
159
Serious AEs
18.2%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model) — 0.27; 0.37 mL/kg/min — p=0.862
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Verinurad (Drug); Allopurinol (Drug); Placebo for verinurad (Drug); Placebo for allopurinol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model) |
0.27; 0.37 | 0.862 |
| SECONDARY Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model) |
0.27; -0.17 | 0.472 |
| SECONDARY Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM) |
0.50; 3.55; 4.31; 1.16 | 0.287 |
| SECONDARY Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM) |
0.50; 2.85; 4.31; 4.45 | 0.960 |
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
Eligibility 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:
- 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 Criteria
- eGFR 110 beats per minute.
Data sourced from ClinicalTrials.gov (NCT04327024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.