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Nitric Oxide for Cardiovascular Disease

Phase 2

Recruiting

Led By Lorenzo Berra, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years of age

Elective cardiac or aortic surgery with CPB >90 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up plasma will be sampled before the cardiac surgery and after the first 48 hours from surgery

Awards & highlights

Study Summary

This trial is testing whether nitric oxide can help reduce oxidative stress in heart surgery patients with endothelial dysfunction.

Who is the study for?

This trial is for adults over 18 with endothelial dysfunction who are undergoing elective cardiac surgery lasting more than 90 minutes. They must be part of another study (NCT02836899) and give consent. Excluded are those with certain heart, kidney conditions, recent contrast infusion or blood transfusions, hemolysis disorders, emergent surgery needs, or a life expectancy under one year.Check my eligibility

What is being tested?

The study tests the effects of inhaling Nitric Oxide gas on plasma reactions in patients during prolonged cardiac surgeries compared to a placebo. It's an add-on to another trial and focuses on how this treatment might help manage oxidative stress related to cardiovascular disease.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally inhaling gases like Nitric Oxide can cause issues such as headache, dizziness, or respiratory problems. Blood withdrawal may lead to bruising or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for heart or aorta surgery lasting more than 90 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ plasma will be sampled before the cardiac surgery and after the first 48 hours from surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~plasma will be sampled before the cardiac surgery and after the first 48 hours from surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and plasma will be sampled before the cardiac surgery and after the first 48 hours from surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in the concentration of glutathione/glutathione disulfide (GSH/GSSG) and the cysteine/ cysteine disulfide (Cys/CysSS) couples in the plasma after cardiac surgery.

Changes in the electrical potential of glutathione/glutathione disulfide (GSH/GSSG) and the cysteine/ cysteine disulfide (Cys/CysSS) couples in the plasma after cardiac surgery.

Secondary outcome measures

Changes of concentration in plasma and red blood cells of nitric oxide metabolites after cardiac surgery.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nitric OxideExperimental Treatment2 Interventions

Inhaled nitric oxide (iNO) will be administered via the cardiopulmonary bypass (CPB) machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the ICU. Test gas administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled nitric oxide (iNO) will be weaned and discontinued.

Group II: NitrogenPlacebo Group2 Interventions

Inhaled nitrogen will be administered via the cardiopulmonary bypass (CPB) machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the Intensive Care Unit (ICU). Test gas administration will commence at the onset of CPB and last for 24 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitric Oxide

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,381 Total Patients Enrolled

1 Trials studying Endothelial Dysfunction

40 Patients Enrolled for Endothelial Dysfunction

Spina, Stefano, M.D., Massachusetts General HospitalUNKNOWN

2 Previous Clinical Trials

290 Total Patients Enrolled

1 Trials studying Endothelial Dysfunction

40 Patients Enrolled for Endothelial Dysfunction

University of SouthamptonOTHER

215 Previous Clinical Trials

2,466,149 Total Patients Enrolled

Media Library

Nitric Oxide Clinical Trial Eligibility Overview. Trial Name: NCT04022161 — Phase 2

Endothelial Dysfunction Research Study Groups: Nitrogen, Nitric Oxide

Endothelial Dysfunction Clinical Trial 2023: Nitric Oxide Highlights & Side Effects. Trial Name: NCT04022161 — Phase 2

Nitric Oxide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04022161 — Phase 2

Frequently Asked Questions

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

Are there any precedents for the use of Nitric Oxide in medical research?

"Presently, there are 24 trials underway for Nitric Oxide. 8 of them have progressed to Phase 3 and can be found in Anchorage, Alaska; with a total of 100 research centres across the world running these experiments."

Answered by AI

What are the associated risks of Nitric Oxide treatment?

"With clinical data existing to support Nitric Oxide's safety, but no efficacy-related information currently available, our team has assigned it a rating of 2."

Answered by AI

What clinical purposes are Nitric Oxide most frequently employed for?

"Nitric Oxide is a commonly used treatment for respiratory failure and can also provide relief from verruca, pulmonary hypertension, and other benign skin lesions."

Answered by AI

Are recruitment efforts ongoing for this research project?

"Per the listing hosted on clinicaltrials.gov, this medical investigation is presently searching for participants. The trial was first listed on July 25th 2019 and recently updated November 9th 2022."

Answered by AI

What is the total participant count of this experiment?

"Affirmative. The clinical trial registry lists this experiment as currently recruiting patients, with a posting date of July 25th 2019 and last edit on November 9th 2022. At present, they are in search of 100 subjects to observe at one site."

Answered by AI

Recent research and studies

BMJ OpenJournal

Protocol of a Randomised Controlled Trial in Cardiac Surgical Patients with Endothelial Dysfunction Aimed to Prevent Postoperative Acute Kidney Injury by Administering Nitric Oxide Gas

Marrazzo, Francesco, Stefano Spina, Francesco Zadek, Tenzing Lama, Changhan Xu, Grant Larson, Emanuele Rezoagli, et al.. 2019. “Protocol of a Randomised Controlled Trial in Cardiac Surgical Patients with Endothelial Dysfunction Aimed to Prevent Postoperative Acute Kidney Injury by Administering Nitric Oxide Gas”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-026848.

clinicaltrials.govStudy

Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients

Lorenzo Berra, MD 2019. "Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04022161.