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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 hour
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Limb Blood Flow
Secondary outcome measures
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

Angiotensin-II, Valsartan Clinical Trial Eligibility Overview. Trial Name: NCT02966665 — Phase 1
High Blood Pressure Research Study Groups: Healthy Older Controls (over 65 years), Hypertension patients, Coronary Angiography patients, Pulmonary Arterial Hypertension patients, Chronic Obstructive Pulmonary Disease patients, Heart Failure patients, Healthy Young Volunteers (18-30 years)
High Blood Pressure Clinical Trial 2023: Angiotensin-II, Valsartan Highlights & Side Effects. Trial Name: NCT02966665 — Phase 1
Angiotensin-II, Valsartan 2023 Treatment Timeline for Medical Study. Trial Name: NCT02966665 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the predetermined participant capacity of this trial?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was originally published on September 1st 2008, is actively recruiting patients. Approximately 420 participants must be enrolled from a single clinical centre."

Answered by AI

How robust is the safety profile of Angiotensin-II, Valsartan?

"Due to the limited amount of data related to efficacy and safety, Angiotensin-II, Valsartan was assigned a score of 1."

Answered by AI

Are there still opportunities for participants to join this research?

"According to clinicaltrials.gov, this medical experiment is still seeking participants; it was first posted on September 1st 2008 and the details were most recently modified on October 3rd 2022."

Answered by AI

What ailments can Angiotensin-II, Valsartan provide relief for?

"Angiotensin-II, Valsartan is most commonly administered during general anesthesia. Additionally, it can be utilized to ameliorate vitamin deficiences and symptoms associated with seasonal allergic rhinitis or pheochromocytomas."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
George E Wahlen VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
: Vascular Function in Health and Disease
Russell Richardson 2008. ": Vascular Function in Health and Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02966665.
All > Pulmonary Arterial Hypertension > Utah
~31 spots leftby Aug 2025
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