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Vascular Function in Pulmonary Arterial Hypertension
Phase 1
Recruiting
Led By Russell Richardson, Ph.D.
Research Sponsored by Russell Richardson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic Obstructive Pulmonary Disease subjects: patients diagnosed with mild to moderate COPD
Pulmonary Arterial Hypertension subjects: patients with idiopathic or heritable Group 1 pulmonary arterial hypertension
Must not have
History of variant angina
History of myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 hour
Awards & highlights
Summary
This trial is designed to study changes in vascular function with advancing age, and also examine peripheral vascular changes in patients suffering from chronic obstructive pulmonary disease (COPD), Sepsis, Pulmonary Hypertension, and cardiovascular disease.
Who is the study for?
This trial is for healthy young adults (18-30), older adults (65+), and patients with mild to moderate COPD, Group 1 pulmonary arterial hypertension, or Class I-III heart failure. Excluded are those with severe diseases like unstable angina, significant renal disease, severe COPD requiring oxygen, recent heart attacks or surgeries, pregnant women, and anyone at risk from MRI.
What is being tested?
The study investigates how blood supply meets tissue demand during exercise in aging and diseases like COPD. It tests the effects of various substances on vascular function: BH4, L-NMMA, vitamins C & E; α-Lipoic Acid; Fexofenadine; Ranitidine; Angiotensin-II; Valsartan; BQ-123; MitoQ through maximum exercise tests and drug responses.
What are the potential side effects?
Potential side effects may include allergic reactions to medications used in the trial such as skin rashes or digestive issues from antihistamines like Fexofenadine. Blood pressure changes could occur due to drugs affecting vascular tone like Angiotensin-II inhibitors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild to moderate COPD.
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I have Group 1 pulmonary arterial hypertension that is idiopathic or heritable.
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I am over 65 and healthy with no conditions affecting study participation.
Select...
I have heart failure symptoms that are mild to moderately severe.
Select...
I have been diagnosed with chronic high blood pressure.
Select...
I am between 18 and 30 years old and healthy with no conditions affecting study participation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of variant angina.
Select...
I have had a heart attack before.
Select...
I have unstable chest pain.
Select...
My kidney function is reduced with a GFR less than 50 mL/min.
Select...
I have severe COPD and need extra oxygen or have very low lung function.
Select...
I have had a procedure to open blocked arteries in my heart.
Select...
I have had surgery to improve blood flow to my heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Limb Blood Flow
Secondary study objectives
Change in Blood Pressure
Change in Maximum Exercise Capacity
Change in Peak Rate of Mitochondrial Adenosine Triphosphate (ATP) Synthesis
Trial Design
7Treatment groups
Experimental Treatment
Group I: Pulmonary Arterial Hypertension patientsExperimental Treatment7 Interventions
Patients with idiopathic or heritable Group 1 pulmonary arterial hypertension, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group II: Hypertension patientsExperimental Treatment7 Interventions
Patients with chronic high blood pressure, but with less than severe hypertension, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group III: Heart Failure patientsExperimental Treatment7 Interventions
Patients with Class I - III New York Heart Association symptoms of Heart Failure who are not anemic or taking medications that affect blood clotting, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group IV: Healthy Young Volunteers (18-30 years)Experimental Treatment7 Interventions
Healthy volunteers between the ages of 18 and 30 years with no diseases or conditions that would affect their participation in the study, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group V: Healthy Older Controls (over 65 years)Experimental Treatment7 Interventions
Healthy volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group VI: Coronary Angiography patientsExperimental Treatment7 Interventions
Patients undergoing routine coronary angiography, but who do not require intracoronary procedures or have history of myocardial disease, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Group VII: Chronic Obstructive Pulmonary Disease patientsExperimental Treatment7 Interventions
Patients diagnosed with mild to moderate COPD, but not severe COPD patients, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BQ-123
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Russell RichardsonLead Sponsor
Russell Richardson, Ph.D.Principal Investigator - George E Wahlen VA Medical Center
University of Utah Hospital
1 Previous Clinical Trials
185 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of variant angina.I have had a heart attack before.I have unstable chest pain.My kidney function is reduced with a GFR less than 50 mL/min.I have been diagnosed with mild to moderate COPD.I have Group 1 pulmonary arterial hypertension that is idiopathic or heritable.I have severe COPD and need extra oxygen or have very low lung function.I have had a procedure to open blocked arteries in my heart.I have had surgery to improve blood flow to my heart.I am over 65 and healthy with no conditions affecting study participation.I have heart failure symptoms that are mild to moderately severe.I cannot have an MRI due to a pacemaker, metal implants, or certain heart valves.Your heart is not pumping blood effectively.I have been diagnosed with chronic high blood pressure.Patients who are scheduled to have a standard coronary angiography procedure.I am between 18 and 30 years old and healthy with no conditions affecting study participation.
Research Study Groups:
This trial has the following groups:- Group 1: Coronary Angiography patients
- Group 2: Healthy Older Controls (over 65 years)
- Group 3: Pulmonary Arterial Hypertension patients
- Group 4: Hypertension patients
- Group 5: Chronic Obstructive Pulmonary Disease patients
- Group 6: Heart Failure patients
- Group 7: Healthy Young Volunteers (18-30 years)
Awards:
This trial has 2 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
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