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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

Approved for 20 Other Conditions

No Placebo-Only Group

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 below

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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.

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I have heart failure symptoms that are mild to moderately severe.

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I have been diagnosed with chronic high blood pressure.

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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:

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I have a history of variant angina.

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I have had a heart attack before.

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I have unstable chest pain.

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My kidney function is reduced with a GFR less than 50 mL/min.

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I have severe COPD and need extra oxygen or have very low lung function.

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I have had a procedure to open blocked arteries in my heart.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 hour for reporting.

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

Awards & Highlights

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.

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

0 / 13Eligibility criteria met