Kline 2017 Am Heart J

Kline JA, Hall C, Jones AE, Pusckarich MA, Mastouri R, Lahm T (2017) Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: the iNOPE trial. Am Heart J 186:100–10.

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Kline JA, Hall C, Jones AE, Pusckarich MA, Mastouri R, Lahm T (2017) Am Heart J

Abstract: The study hypothesis is that administration of inhaled NO plus oxygen to subjects with submassive pulmonary embolism (PE) will improve RV systolic function; reduce RV strain and necrosis while improving patient dyspnea more than treatment with oxygen alone.

This paper describes the rationale and protocol for a registered (NCT01939301), a nearly completed Phase II, three-center, randomized, double blind, controlled trial. Eligible patients have pulmonary imaging-proven acute PE. Subjects must be normotensive, 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 h) with blood sampling before and after treatment, and mandatory echocardiography and high sensitivity troponin post treatment to assess the composite primary endpoint. 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=0.05 and β=0.20. Safety was ensured by continuous spectrophotometric monitoring 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 No patient has been withdrawn stopped as a result of a safety concern, and no patient has had a serious adverse event related to NO.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.

• Bioblast editor: Kandolf G • O2k-Network Lab: US IN Indianapolis Kline JA

Labels: MiParea: Respiration, Patients, Pharmacology;toxicology  Pathology: Other 

Organism: Human  Tissue;cell: Blood cells, Platelet 

HRR: Oxygraph-2k