Study of verinurad and allopurinol in heart failure with preserved ejection fractio
- Conditions
- Heart Failure Patients with Preserved Ejection Fraction (HFpEF) and hyperuricaemiaMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-004862-16-AT
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>allopurinol monotherapy on exercise capacity<br>2. To assess effect of verinurad + allopurinol compared to <br>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 Outcome Measures
Name Time Method 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