Heart Failure With Preserved Ejection Fraction (HFpEF)Phase 2AMETHYSTNCT04327024
Study of Verinurad in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Verinurad and Allopurinol in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by AstraZeneca at 58 sites in 12 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 130 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF)
- What is being tested?
- Verinurad and Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 58 sitesin 12 countries
- Study dates
- 19 May 2020to 29 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
58 sites in 12 countries.
58 sites in 12 countries
United States8 sites
Research Site
Granada Hills, California, 91344
Research Site
Miami, Florida, 33135
Research Site
Norfolk, Virginia, 23510
Research Site
Northridge, California, 91324
Research Site
Pembroke Pines, Florida, 33024
Research Site
Port Orange, Florida, 32127
Research Site
Torrance, California, 90502
Research Site
Winston-Salem, North Carolina, 27157
Poland8 sites
Research Site
Bydgoszcz, 85-079
Research Site
Chojnice, 89-600
Research Site
Chrzanów, 32-500
Research Site
Lublin, 20-362
Research Site
Tychy, 43-100
Research Site
Warsaw, 02-097
Research Site
Warsaw, 02-637
Research Site
Warsaw, 04-628
Argentina6 sites
Research Site
CABA, C1006ACC
Research Site
CABA, C1119ACN
Research Site
CABA, C1425AGC
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600GNY
Research Site
Rosario, 2000
Germany6 sites
Research Site
Bad Oeynhausen, 32545
Research Site
Berlin, 10789
Research Site
Berlin, 13353
Research Site
Göttingen, 37075
Research Site
Regensburg, 93053
Research Site
Würzburg, 97078
Russia6 sites
Research Site
Aramil, 624002
Research Site
Kemerovo, 650002
Research Site
Novosibirsk, 630055
Research Site
Saint Petersburg, 195067
Research Site
Saint Petersburg, 199226
Research Site
Tomsk, 634012
South Korea6 sites
Research Site
Cheongju-si, 28644
Research Site
Gangwon-do, 26426
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 08308
Australia4 sites
Research Site
Bedford Park, 5042
Research Site
Chermside, 4032
Research Site
Geelong, 3220
Research Site
Milton, 4064
Canada4 sites
Research Site
Québec, Quebec, G1G 3Y8
Research Site
Québec, Quebec, G1V 4G5
Research Site
Québec, Quebec, G2J 0C4
Research Site
Québec, Quebec, G3K 2P8
Slovakia4 sites
Research Site
Brezno, 97742
Research Site
Lučenec, 984 01
Research Site
Prešov, 080 01
Research Site
Svidník, 08901
Bulgaria3 sites
Research Site
Plovdiv, 4004
Research Site
Sofia, 1000
Research Site
Sofia, 1431
About this study
Official title: A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction
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
Read the 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 correlates with other markers of poor prognosis in HF patients with preserved ejection fraction (HFpEF), and an estimated 1/2-2/3 of HFpEF patients have hyperuricaemia. HFpEF is a microvascular disease likely partly driven by endothelial dysfunction and inflammation in coronary vessel walls. Uric acid crystals have been identified in coronary vessel walls in some hyperuricaemic patients.
Uric acid transporter 1 (URAT1) is responsible for reabsorption of uric acid (UA) in the proximal tubule. Inhibition of URAT1 results in increased urinary excretion of UA and lowering of uric acid in the blood. Verinurad is a novel URAT1 inhibitor in Phase 2 development for chronic kidney disease (CKD) and HF. Verinurad combined with the xanthine oxidase (XO) inhibitors (XOI) febuxostat or allopurinol has been shown to lower sUA in patients with recurrent gout in Phase 2 studies by up to approximately 80%.
The primary objective of this Phase 2 study is to assess the effect of a combination of verinurad and allopurinol on exercise capacity in patients with HFpEF.
The secondary objectives are to assess effect of combination of verinurad and allopurinol in comparison to allopurinol monotheraphy on excercise capacity dwhich will be measured in peak VO2 as well as effect of verinurad and allopurinol compared to placebo and to allopurinol monotheraphy on Kansas City cardiomyopathy questionnaire (KCCQ)-total symptom score (TSS). A sub-study aims to investigate the relationship between UA crystals and inflammation.
- Being tested
- Verinurad, Allopurinol, Placebo for verinurad, Placebo for allopurinol
- Keywords
- Phase 2,, Double-Blind,, Placebo and Active Control,, Verinurad,, Allopurinol,, HFpEF,, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerinuradDrug
Also called verinurad titration 3 - 7.5 - 12mg, allopurinol titration 100 - 200 - 300 mg
The treatment will be titrated in 3 steps for target low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg) of verinurad.
Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol.
AllopurinolDrug
Also called allopurinol titration 100 - 200 - 300 mg
Study treatments will be titrated in 3 steps: Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol
Placebo for verinuradDrug
Also called Placebo
Matching Capsule
Placebo for allopurinolDrug
Also called Placebo
Matching tablet
| Study group | Role | What they receive |
|---|---|---|
| Verinurad 12 + allopurinol | Experimental | Dose [mg] verinurad/allopurinol:
Step 1 - titration_3/100 Step 2 - titration_7.5/200 Step 3 - target dose 12/300 Receives: Drug: Verinurad; Drug: Allopurinol |
| Allopurinol alone | Experimental | Dose [mg] verinurad/allopurinol:
Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose 0/300 Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Placebo [mg] in 3 steps 0/0 Receives: Drug: Placebo for verinurad; Drug: Placebo for allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model)
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate.
H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0
A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level.
Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.
Measured: From baseline to Week 32
Secondary outcomes (3)
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model)
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate.
H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) ≠ 0
A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level.
Measured: From baseline to Week 32
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status).
Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates.
The number analyzed at each timepoint represents the number of subjects with data at each visit.
Measured: From baseline to Week 22 and Week 32
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status).
Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates.
The number analyzed at each timepoint represents the number of subjects with data at each visit.
Measured: From baseline to Week 22 and Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start19 May 2020
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalane Kitzman, MD, Principal investigator, 1326 Riverview Road Ext Lexington, NC 27292-1764 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327024
- Sponsor's protocol ID
- D5496C00005
- Other IDs
- 2019-004862-16, 2019
- Acronym
- AMETHYST
- Status last verified
- Jun 2023
- First submitted
- 13 Mar 2020
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Publications
Kitzman DW, Voors AA, Mentz RJ, Lewis GD, Perl S, Myte R, Kaguthi G, Sjostrom CD, Kallgren C, Shah SJ. Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: The AMETHYST Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):892-900. doi: 10.1001/jamacardio.2024.2435.
PubMed 39141378
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04327024
- Acronym / sponsor ID
- AMETHYST / D5496C00005
- Keywords
- Phase 2,, Double-Blind,, Placebo and Active Control,, Verinurad,, Allopurinol,, HFpEF,, Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 May 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 correlates with other markers of poor prognosis in HF patients with preserved ejection fraction (HFpEF), and an estimated 1/2-2/3 of HFpEF patients have hyperuricaemia. HFpEF is a microvascular disease likely partly driven by endothelial dysfunction and inflammation in coronary vessel walls. Uric acid crystals have been identified in coronary vessel walls in some hyperuricaemic patients.
Uric acid transporter 1 (URAT1) is responsible for reabsorption of uric acid (UA) in the proximal tubule. Inhibition of URAT1 results in increased urinary excretion of UA and lowering of uric acid in the blood. Verinurad is a novel URAT1 inhibitor in Phase 2 development for chronic kidney disease (CKD) and HF. Verinurad combined with the xanthine oxidase (XO) inhibitors (XOI) febuxostat or allopurinol has been shown to lower sUA in patients with recurrent gout in Phase 2 studies by up to approximately 80%.
The primary objective of this Phase 2 study is to assess the effect of a combination of verinurad and allopurinol on exercise capacity in patients with HFpEF.
The secondary objectives are to assess effect of combination of verinurad and allopurinol in comparison to allopurinol monotheraphy on excercise capacity dwhich will be measured in peak VO2 as well as effect of verinurad and allopurinol compared to placebo and to allopurinol monotheraphy on Kansas City cardiomyopathy questionnaire (KCCQ)-total symptom score (TSS). A sub-study aims to investigate the relationship between UA crystals and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verinurad 12 + allopurinol | Experimental | Drug: Verinurad, Drug: AllopurinolDose [mg] verinurad/allopurinol: Step 1 - titration_3/100 Step 2 - titration_7.5/200 Step 3 - target dose 12/300 |
| Allopurinol alone | Experimental | Drug: AllopurinolDose [mg] verinurad/allopurinol: Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose 0/300 |
| Placebo | Placebo comparator | Drug: Placebo for verinurad, Drug: Placebo for allopurinolPlacebo [mg] in 3 steps 0/0 |
Who may qualify
- Ages
- 40 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerinuradAlso: verinurad titration 3 - 7.5 - 12mg, allopurinol titration 100 - 200 - 300 mgThe treatment will be titrated in 3 steps for target low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg) of verinurad. Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol. | Drug | Verinurad 12 + allopurinol |
| AllopurinolAlso: allopurinol titration 100 - 200 - 300 mgStudy treatments will be titrated in 3 steps: Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol | Drug | Allopurinol alone, Verinurad 12 + allopurinol |
| Placebo for verinuradAlso: PlaceboMatching Capsule | Drug | Placebo |
| Placebo for allopurinolAlso: PlaceboMatching tablet | Drug | Placebo |
Primary outcome
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model)
Time frame: From baseline to Week 32
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level. Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.
3 secondary outcomes
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model)
Time frame: From baseline to Week 32
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
Time frame: From baseline to Week 22 and Week 32
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
Time frame: From baseline to Week 22 and Week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39141378Kitzman DW, Voors AA, Mentz RJ, Lewis GD, Perl S, Myte R, Kaguthi G, Sjostrom CD, Kallgren C, Shah SJ. Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: The AMETHYST Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):892-900. doi: 10.1001/jamacardio.2024.2435.
- Clinical Study Protocol RedactedLink provided by the sponsor.
- CSR\_synopsis\_redactedLink provided by the sponsor.
- Statistical Analysis Plan-redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalane Kitzman, MD principal investigator
1326 Riverview Road Ext Lexington, NC 27292-1764 USA
58 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verinurad and Allopurinol in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by AstraZeneca at 58 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Poland, Argentina, Germany, Russia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model) (time frame: From baseline to Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.