: Vascular Function in Health and Disease

PHASE1RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Chronic Obstructive Pulmonary DiseasePulmonary Artery HypertensionHeart FailureHypertension
Interventions
OTHER

Maximum Exercise Tests

Graded exercise test to volitional exhaustion (stationary bike or treadmill), maximal handgrip test, maximal leg extension test, and maximal plantar flexion test.

DRUG

BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate

Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, passive leg movement test, exercise bouts, electromyography and exercise training regimen at baseline and following treatment with Nitric Oxide blockade via infusion of N-monomethyl-L-arginine (L-NMMA) (0.4 mg/kg/min), antioxidant cocktail (Vitamin C, Vitamin E, alpha-lipoic acid) ingestion, L-ascorbate injection, BH4 ingestion.

DRUG

BQ-123

Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with endothelin-1 receptor antagonist BQ-123 (D-tryptamine-D-aspartic acid-L-proline-D-valine-L-leucine).

DRUG

Fexofenadine, Ranitidine

Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with Histamine H1 receptor antagonist fexofenadine (Allegra) and Histamine H2 receptor antagonist ranitidine (Zantac).

OTHER

Angiotensin-II, Valsartan

Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement, and exercise bouts at baseline and following treatment with Angiotensin-II receptor agonist (angiotensin-II) and antagonist Valsartan (Diovan).

DRUG

Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine

Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement; vasodilation with nitroglycerin followed by Angiotensin-II and Alpha Adrenergic blockade with infusions of Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine and Phentolamine (Regitine).

DRUG

BQ-123, MitoQ, BH4

Catheter placement in femoral artery and femoral vein and muscle biopsy; Nuclear Magnetic Resonance (NMR) scanning and exercise bouts at baseline and following treatment with BQ-123 with or without oral mitochondria-targeted antioxidant (MitoQ) or oral BH4.

Trial Locations (1)

84132

RECRUITING

George E Wahlen VA Medical Center, Salt Lake City

All Listed Sponsors
lead

Russell Richardson

OTHER

NCT02966665 - : Vascular Function in Health and Disease | Biotech Hunter | Biotech Hunter