NCT05888233 Allopurinol Improves Heart Function in African Americans With Resistant Hypertension
| NCT ID | NCT05888233 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Heart Failure Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-09-30 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
African American adults in the United States have the highest prevalence rate of high blood pressure (hypertension) and heart failure in the world. African Americans with treatment resistant hypertension have higher levels of the enzyme - xanthine oxidase compared to Caucasians. This trial will test if administration of the xanthine oxidase inhibitor - Allopurinol (commonly used in the treatment of gout), given over a period of 8 weeks, will improve heart function, exercise ability and quality of life in African American Veterans with resistant hypertension.
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Veteran 2. African American 3. Resistant hypertension diagnosis (defined as blood pressure greater than 140/90 mmHg at 2 clinic visits despite the use of 3 antihypertensive medications at pharmacologically effective doses) 4. Locale - Birmingham, AL and surrounding areas Exclusion Criteria: 1. History of heart failure 2. Chronic kidney disease (estimated creatinine clearance \< 60 ml/min) 3. Chronic steroid therapy 4. Known coronary artery disease 5. Known causes of secondary hypertension 6. Already taking Allopurinol Magnetic Resonance Imaging Exclusion 1. Claustrophobia 2. Cardiac implantable electronic device (permanent pacemaker and/or intracardiac defibrillator) 3. Metal clips and/devices or other item that specifically prohibit safe CMR
Contact & Investigator
Louis J Dellitalia, MD
PRINCIPAL INVESTIGATOR
Birmingham VA Medical Center, Birmingham, AL
Frequently Asked Questions
Who can join the NCT05888233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Heart Failure Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05888233 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05888233 currently recruiting?
Yes, NCT05888233 is actively recruiting participants. Contact the research team at Louis.Dellitalia@va.gov for enrollment information.
Where is the NCT05888233 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05888233 clinical trial?
NCT05888233 is sponsored by VA Office of Research and Development. The principal investigator is Louis J Dellitalia, MD at Birmingham VA Medical Center, Birmingham, AL. The trial plans to enroll 50 participants.
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