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NCT04231773: iNO
The Effect of Inhaled Nitric Oxide on Maximal Oxygen Consumption During Exercise in Hypoxia
Phase 1, PHASE2 trial testing Nitric Oxide in Hypoxia in 20 participants. Completed in 4 December 2021.
4 December 2021
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 20 |
| Start date | 17 August 2020 |
| Primary completion | 4 December 2021 |
| Estimated completion | 4 December 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Nitric Oxide (NITRIC OXIDE) — full drug profile →
- Placebo
Conditions studied
- Hypoxia — all drugs for Hypoxia →
Sponsor
University of Alberta
Who can join
Adults 18 to 45, any sex, with Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During exercise in conditions of low oxygen (termed hypoxia), such as mountaineering at high altitudes, the lung blood vessels constrict in an attempt to protect the body from the negative effects of hypoxia. It appears that this blood vessel constriction may limit the heart to pump blood during heavy exercise, leading to reductions in exercise performance. Inhaled nitric oxide is a drug that is known to relax the lung blood vessels. Inhaled nitric oxide has been used to relax lung blood vessels and improve exercise capacity in patients with chronic disease. It is unknown if similar improvements would be observed during exercise in healthy individuals when exposed to low levels of oxygen. The goal of this study is to determine if inhaled nitric oxide can relax the lung blood vessels and improve the heart's pumping ability during exercise in low oxygen conditions. Further, the investigators will determine if these improvements in lung blood vessel and heart function increase exercise performance. Participants will complete 6 sessions over a three week period where they will perform exercise challenges while breathing low levels of oxygen with and without inhaled nitric oxide. The low oxygen conditions will be comparable to being at an altitude of 14,000-17,000 feet. 17,000 feet would be equivalent to standing on the summit of King Peak in the Yukon (the 4th tallest mountain in Canada).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04231773
- 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.
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- 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 Hypoxia
Currently open trials in the same condition.
- NCT07479511 — Adaptation of Lung Transplant Recipients at Extreme Altitude · active not recruiting
- NCT07287293 — Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia · NA · recruiting
- NCT07389083 — The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Broncho · NA · recruiting
- NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting
- NCT07408388 — Pulse Oximeter Accuracy During Stable Hypoxia Plateaus · active not recruiting
Other University of Alberta trials
Trials by the same sponsor.
- NCT03240900 — Electrical Stimulation for Improving Postoperative Breast Sensation · NA · not yet recruiting
- NCT04231760 — The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD · Phase 1, PHASE2 · not yet recruiting
- NCT06649604 — Reducing Pain From Retinal Laser With Vibrational Stimulation · NA · not yet recruiting
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT06920914 — Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD · NA · 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 NCT04231773 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alberta
- Last refreshed: 19 September 2024
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