Last reviewed · How we verify
NCT03748082
Effects of Nitric Oxide on Vascular Responsiveness and on Endothelial Cells During Hemolysis in Patients With Pre-operative Endothelial Dysfunction Undergoing Prolonged Cardiopulmonary Bypass.
Phase 2 trial testing Nitric Oxide in Endothelial Dysfunction. Withdrawn.
1 November 2023
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Start date | 5 December 2018 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Nitric Oxide (NITRIC OXIDE) — full drug profile →
- Reactive Hyperemia Index
- Endothelial Cells Collection
Conditions studied
- Endothelial Dysfunction — all drugs for Endothelial Dysfunction →
- Hemolysis Intravascular — all drugs for Hemolysis Intravascular →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
Sponsor
Massachusetts General Hospital
Who can join
18 and older, any sex, with Endothelial Dysfunction or Hemolysis Intravascular. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Reactive Hyperemia Index (RHI)
Time frame: The test will be performed perioperatively before anesthesia induction and at 24 hours after CPB during ICU admission.
A finger plethysmograph will measure the transient increase in forearm blood flow (Reactive Hyperemia Index, RHI) in response to a 5 minutes occlusion of the brachial artery with a pressure cuff (Peripheral Artery Tonometry).
Sponsor's own description
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical Applications for Gasotransmitters in the Cardiovascular System: Are We There Yet?
Arrigo E, Comità S, Pagliaro P, Penna C, et al · · 2023 · cited 9× · PMID 37569855 · DOI 10.3390/ijms241512480
Verify or expand the search:
- PubMed search for NCT03748082
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nitric Oxide
Trials testing the same drug.
- NCT05801224 — Vascular ARDS Recruitment After Inhaled Nitric Oxide · NA · suspended
- NCT06622291 — Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients · Phase 4 · completed
- NCT04181359 — The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease. · Phase 1, PHASE2 · withdrawn
- NCT06120816 — Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis · Phase 1 · completed
- NCT06660784 — Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance · active not recruiting
Other recruiting trials for Endothelial Dysfunction
Currently open trials in the same condition.
- NCT07487363 — TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD · Phase 1, PHASE2 · recruiting
- NCT07422974 — Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer · recruiting
- NCT06419959 — NightWare and Cardiovascular Health in Veterans With PTSD · NA · recruiting
- NCT07227727 — Endothelial Dysfunction After SCI · recruiting
- NCT07227740 — Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03748082 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 24 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03748082.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing