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Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial
Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial
- Source :
- American Heart Journal. 186:100-110
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- The study hypothesis is that administration of inhaled nitric oxide (NO) plus oxygen to subjects with submassive pulmonary embolism (PE) will improve right ventricular (RV) systolic function and reduce RV strain and necrosis, while improving patient dyspnea, more than treatment with oxygen alone.This article describes the rationale and protocol for a registered (NCT01939301), nearly completed phase II, 3-center, randomized, double-blind, controlled trial. Eligible patients have pulmonary imaging-proven acute PE. Subjects must be normotensive, and have RV dysfunction on echocardiography or elevated troponin or brain natriuretic peptide and no fibrinolytics. Subjects receive NO plus oxygen or placebo for 24 hours (±3 hours) with blood sampling before and after treatment, and mandatory echocardiography and high-sensitivity troponin posttreatment to assess the composite primary end point. The sample size of N=78 was predicated on 30% more NO-treated patients having a normal high-sensitivity troponin (14 pg/mL) and a normal RV on echocardiography at 24 hours with α=.05 and β=.20. Safety was ensured by continuous spectrophotometric monitoring of percentage of methemoglobinemia and a predefined protocol to respond to emergent changes in condition. Blinding was ensured by identical tanks, software, and physical shielding of the device display and query of the clinical care team to assess blinding efficacy.We have enrolled 78 patients over a 31-month period. No patient has been withdrawn as a result of a safety concern, and no patient has had a serious adverse event related to NO.We present methods and a protocol for the first double-blinded, randomized trial of inhaled NO to treat PE.
- Subjects :
- Adult
medicine.medical_specialty
030204 cardiovascular system & hematology
Nitric Oxide
Placebo
Article
law.invention
Young Adult
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Administration, Inhalation
Clinical endpoint
Humans
Medicine
Intensive care medicine
biology
business.industry
Oxygen Inhalation Therapy
Brain natriuretic peptide
medicine.disease
Combined Modality Therapy
Troponin
Bronchodilator Agents
Pulmonary embolism
Clinical trial
030228 respiratory system
Anesthesia
Ventricular Function, Right
biology.protein
Pulmonary Embolism
Cardiology and Cardiovascular Medicine
business
Blood sampling
Subjects
Details
- ISSN :
- 00028703
- Volume :
- 186
- Database :
- OpenAIRE
- Journal :
- American Heart Journal
- Accession number :
- edsair.doi.dedup.....f1eab046d0170ddba234217ea176fa98
- Full Text :
- https://doi.org/10.1016/j.ahj.2017.01.011