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Xanthine Oxidase Inhibitor
Allopurinol for Resistant Hypertension (RESIST Trial)
Phase 2
Recruiting
Led By Louis J Dellitalia, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of resistant hypertension (defined as blood pressure greater than 140/90 mmHg at 2 clinic visits despite the use of 3 antihypertensive medications at pharmacologically effective doses)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
RESIST Trial Summary
This trial will test if a common gout drug, given over 8 weeks, can help African American Veterans with high blood pressure and heart failure.
Who is the study for?
This trial is for African American veterans in Birmingham, AL with resistant hypertension, which means their blood pressure remains high despite taking three different blood pressure medications. They must not have heart failure, kidney disease, coronary artery disease or be on chronic steroid therapy. Also excluded are those already on Allopurinol or with conditions that prevent safe CMR imaging.Check my eligibility
What is being tested?
The study tests whether Allopurinol can improve heart function and quality of life over an 8-week period in African Americans who have high blood pressure that doesn't respond to standard treatments. It explores if lowering xanthine oxidase levels with this medication used for gout makes a difference.See study design
What are the potential side effects?
Allopurinol may cause side effects like skin rash, digestive problems, liver issues and rarely more serious allergic reactions. Since it's often used to treat gout without major issues, severe side effects are uncommon but possible.
RESIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure remains high despite taking 3 different blood pressure medications.
RESIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LV end-diastolic fractional shortening
LV end-diastolic mass index
LV end-diastolic mid-wall radius to wall thickness ratio
+6 moreSecondary outcome measures
Brain Natriuretic Peptide
Diastolic Blood Pressure
Systolic Blood Pressure
+2 moreSide effects data
From 2019 Phase 3 trial • 530 Patients • NCT0201717116%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Influenza like illness
6%
Urinary tract infection
6%
Sinusitis
6%
Diabetic ketoacidosis
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Osteomyelitis
2%
Abortion spontaneous
1%
Diarrhoea
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Chest pain
1%
Pancreatitis acute
1%
Asthma
1%
Coronary artery disease
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Cardiac arrest
1%
Hyperglycaemia
1%
Death
1%
Cellulitis
1%
Staphylococcal infection
1%
Road traffic accident
1%
Renal failure acute
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Hyperemesis gravidarum
1%
Angina unstable
1%
Impaired gastric emptying
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo
RESIST Trial Design
1Treatment groups
Experimental Treatment
Group I: Allopurinol - African American VeteransExperimental Treatment1 Intervention
Subjects will receive Allopurinol (300mg/daily) for 4 weeks. If tolerated, dose will be increased to 600mg/daily for an additional 4 weeks. Subjects will take Allopurinol (300-600mg/daily) for 8 weeks total
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allopurinol
1999
Completed Phase 4
~6150
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,234 Total Patients Enrolled
38 Trials studying Heart Failure
63,138 Patients Enrolled for Heart Failure
Louis J Dellitalia, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: You are of African American descent.I am currently taking Allopurinol.This criterion is very broad and needs more context. "Veteran" could refer to someone who has served in the military, but it's not clear how this relates to a clinical trial exclusion criteria. Can you provide more information or context for this criterion?My blood pressure remains high despite taking 3 different blood pressure medications.My kidneys do not work well (poor kidney function).I am on long-term steroid medication.I have been diagnosed with heart artery disease.I have a history of heart failure.You are afraid of small or enclosed spaces.I have a condition that causes high blood pressure.You live in or near Birmingham, Alabama.
Research Study Groups:
This trial has the following groups:- Group 1: Allopurinol - African American Veterans
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical research targeting geriatric participants?
"In agreement with the study criteria, those wishing to take part must be over 18 and no older than 75 years of age."
Answered by AI
Can I register for this clinical experiment?
"To participate in this study, participants must have a history of heart failure and range between 18 to 75 years old. This initiative is looking for 50 individuals overall."
Answered by AI
Has the FDA authorized Allopurinol - African American Veterans for use?
"By our reckoning, the safety of Allopurinol - African American Veterans is rated a 2 since there has been some evidence to back its security but none that confirm it is effective."
Answered by AI
Are any more participants able to join this trial at the present time?
"As indicated on clinicaltrials.gov, the current trial is not actively recruiting - it was initially posted 6/1/2023 and last updated 5/23/2023. However, there are 1,435 other studies presently looking for patients to join their research."
Answered by AI
What are the chief aims of this research initiative?
"The primary metric evaluated over the 8-week period is a Six minute walk test. Other secondary objectives include assessing changes in xanthine oxidase activity, mitochondrial DNA damage-associated molecular patterns, and brain natriuretic peptide after Allopurinol administration."
Answered by AI
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