Clinical trials: Nitrite
Heart Disease, Heart Failure With Preserved Ejection Fraction
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics…
- Conditions
- Heart Disease, Heart Failure With Preserved Ejection Fraction, Exercise Intolerance, Pulmonary Hypertension
- Trial name
- NCT01932606
- Testing
- Nitrite
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Barry Borlaug
Diabetes
Nitrite Infusion in Islet Cell Transplantation
This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.
- Trial name
- NCT03544242
- Testing
- Control, Pre-Isolation Infusion, Post-Isolation Infusion
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Alabama at Birmingham
Heart Failure
Oral Nitrite for Older Heart Failure Patients
Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise.
- Trial name
- ONTx+HF (NCT02457260)
- Testing
- 14 N Sodium Nitrite
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Gladwin, Mark, MD
Pulmonary Hypertension, Heart Failure, Diastolic
Inhaled Nitrite in Subjects With Pulmonary Hypertension
This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with pulmonary hypertension…
- Trial name
- NCT01431313
- Testing
- Inhaled Nitrite
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Schmidhofer, Mark, MD
Sickle Cell Disease
Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease
This study will determine if administration of sodium nitrite is safe and can improve small vessel blood flow and tissue oxygenation when given as an additional treatment in patients with acute vaso-occlusive crisis (pain crisis)…
- Trial name
- NCT01033227
- Testing
- sodium nitrite injection, usp
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital Los Angeles
Primary Graft Dysfunction
Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction
This is a Phase 2 observational nonrandomized pilot investigation to evaluate the safety and efficacy of Sodium Nitrite administration for the reduction of Primary Graft Dysfunction (PGD) in patients undergoing lung transplant.
- Trial name
- NCT01715883
- Testing
- Sodium Nitrite
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Gladwin, Mark, MD
Focus of Study of Healthy Adults
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult…
- Trial name
- NCT01681836
- Testing
- 15Nitrogen(15N)-labeled sodium nitrite, 15Nitrogen(15N)-labeled sodium nitrate
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Gladwin, Mark, MD
Heart Failure
Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and…
- Trial name
- NCT02262078
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Mayo Clinic
Heart Failure
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction
This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and…
- Trial name
- ONOH (NCT02918552)
- Testing
- sodium nitrite, Control
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Gladwin, Mark, MD
Sickle Cell Disease
Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
The investigators are conducting a Phase II prospective and placebo controlled study of a topical cream containing sodium nitrite compared to the current standard of care.
- Trial name
- NCT02863068
- Testing
- Topical Sodium Nitrite
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- caterina P minniti
Heart Failure
Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF
A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing.
- Trial name
- INDIE-HFpEF (NCT02742129)
- Testing
- Nebulized Sodium Nitrite
- Where
- 20 sites in United States
- Volunteers
- 105 people
- Sponsor
- Adrian Hernandez
Chronic Kidney Disease
Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial
The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.
- Trial name
- NICE (NCT02552888)
- Testing
- Immediate release sodium nitrite, Isoquercetin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Tulane University
Subarachnoid Hemorrhage
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
- Trial name
- NCT00873015
- Testing
- Sodium nitrite, Saline
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Hope Pharmaceuticals
Pulmonary Hypertension Secondary, Heart Failure
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart…
- Trial name
- PH-HFpEF (NCT03015402)
- Testing
- Sodium Nitrite
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of Pittsburgh
Metabolic Syndrome, Hypertension
Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
This research study is being conducted to examine the effects of daily inorganic nitrite treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese adults with the metabolic syndrome and high blood…
- Trial name
- ONTX (NCT01681810)
- Testing
- 14Nitrogen Sodium Nitrite
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Gladwin, Mark, MD
Long COVID, Cardiorespiratory Fitness
Nitrite Supplementation in Long COVID Patients
Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID.
- Trial name
- NCT05618574
- Testing
- 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- VA Office of Research and Development
Subarachnoid Hemorrhage
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.
- Trial name
- NCT02176837
- Testing
- Sodium Nitrite
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Hope Pharmaceuticals
Acute Myocardial Infarction
Sodium Nitrite in Acute Myocardial Infarction
The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.
- Trial name
- NCT00924118
- Testing
- Sodium Nitrite
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Vascular Aging
Sodium Nitrite to Treat Arterial Aging
The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults.
- Trial name
- NCT02022670
- Testing
- Sodium Nitrite
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Boulder
Out-Of-Hospital Cardiac Arrest
Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV…
- Trial name
- SNOCAT (NCT03452917)
- Testing
- sodium nitrite 45 mg, sodium nitrite 60 mg
- Where
- United States
- Volunteers
- 1,502 people
- Sponsor
- University of Washington