EUCTR2019-004862-16-SK
Active, not recruiting
Phase 1
A Phase 2, MulticEntre, Double-Blind, THree-Arm, Placebo and Active Control Efficacy andSafetY STudy to Evaluate Verinurad combined with Allopurinol in Heart Failure withPreserved Ejection Fraction - AMETHYST
ConditionsHeart 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]
DrugsAllopurinol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart Failure Patients with Preserved Ejection Fraction (HFpEF) and hyperuricaemia
- Sponsor
- AstraZeneca AB
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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:
- •(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
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 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
Outcomes
Primary Outcomes
Not specified
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