sodium nitrite oral (TV 1001) / TheraVasc - LARVOL DELTA

Effects of Oral Sodium Nitrite on Blood Pressure, Insulin Sensitivity, and Intima-Media Arterial Thickening in Adults With Hypertension and Metabolic Syndrome. (PubMed, Hypertension) - P2 | "Nitrite may be a safe therapy to concominantly improve multiple features of the metabolic syndrome including hypertension, insulin resistance, and endothelial dysfunction. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01681810."

Clinical • Journal • Diabetes • Hypertension • Metabolic Disorders

ACC: The role of sodium nitrite in out-of-hospital cardiac arrest (PracticeUpdate) - "Sodium nitrite is felt to be a free radical scavenger. It is felt to reduce inflammation around reperfusion injury, and there was a lot of hope that in patients who have had an out-of-hospital cardiac arrest, trying to stop that reperfusion injury and neurologic damage would improve long-term outcomes, and it's felt that the cooling therapeutic temperature management, or TTM, improves neurologic outcomes by, again, by reducing inflammation after the initial anoxic injury from an out-of-hospital cardiac arrest."

Interview • Video

Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Barry Borlaug; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Apr 2020 ➔ Dec 2020

Trial completion date • Trial primary completion date

Nitrite treatment downregulates vascular MMP-2 activity and inhibits vascular remodeling in hypertension independently of its antihypertensive effects. (PubMed, Free Radic Biol Med) - "We examined the effects of oral sodium nitrite at antihypertensive (15 mg/kg) or non-antihypertensive (1 mg/kg) daily dose in hypertensive rats (two kidney, one clip; 2K1C model)...This effect was fully inhibited by the xanthine oxidase (XOR) inhibitor febuxostat, suggesting XOR-mediated generation of nitric oxide (NO) from nitrite as a mechanism explaining the responses to nitrite...This response is mediated, at least in part, by XOR and is attributable to antioxidant effects of nitrite blunting vascular MMP-2 activation. Our findings suggest nitrite therapy to reverse structural alterations of hypertension."

Journal

Nitrite, Isoquercetin, and Endothelial Dysfunction Trial (NICE trial): Design and Preliminary Data (KIDNEY WEEK 2019) - "35 patients were randomly assigned to oral combination of immediate-release sodium nitrite (40 mg twice daily) and isoquercetin (225 mg, once daily) or placebo for 3 months...Larger trial is warranted to confirm those findings. Funding Other NIH Support"

Acute Hemodynamic Effects of Oral Nitrite in PH-HFpEF (ATS 2019) - P2; "...We are actively enrolling patients with the intent to provide open label oral sodium nitrite to ten patients.Results :Ten patients have currently been enrolled in the cross-over trial, of which five have required a screening RHC and have been given open label oral nitrite...Administration of oral nitrite acutely results in an improvement of right ventricular and left ventricular filling pressures without any significant reduction in cardiac output, cardiac index, or mean arterial pressure. Oral nitrite may be a novel therapeutic agent for patients with PH-HFpEF."