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March 23, 2026Circulation Journal1 citationsOpen Access

A Phase 2, Randomized, Clinical Trial of Inhaled Nitric Oxide for Acute Severe Right Heart Failure With Pulmonary Hypertension (PHiNO Study)

TOTakeshi OgoJUJin UedaATAkihiro Tsuji

Key Result

Inhaled nitric oxide reduced pulmonary vascular resistance by 3.21 Wood units compared to control at 30 minutes in patients with acute severe right heart failure and pulmonary hypertension.

Key Points

  • The research aims to assess the efficacy and safety of inhaled nitric oxide in treating acute severe right heart failure with pulmonary hypertension.
  • Phase 2 randomized clinical trial design
  • Administration of inhaled nitric oxide at 800 ppm
  • Evaluation of patient outcomes related to right heart failure and pulmonary hypertension
  • Efficacy of inhaled nitric oxide in improving hemodynamic stability
  • Positive effects observed on pulmonary pressure reduction
  • Safety profile indicates manageable side effects in the treatment cohort

Study Design

Type

RCT (n=30)

Blinding

Open-label

Randomization

1:1

Multicenter

No

Structured PICO

Does inhaled nitric oxide reduce pulmonary vascular resistance in patients with acute severe right heart failure due to pulmonary hypertension?

P
Population
Patients with acute severe right heart failure (RHF) due to pulmonary hypertension (PAH or CTEPH)
I
Intervention
Inhaled nitric oxide (iNO) 800 ppm via face mask
C
Comparator
Control group not receiving iNO (conventional therapy administered after 30 minutes)
O
Outcome
Change in pulmonary vascular resistance (PVR) from baseline to 30 minutessurrogate

Inhaled nitric oxide rapidly and safely reduces pulmonary vascular resistance and improves markers of right ventricular overload in patients with acute severe right heart failure due to pulmonary hypertension.

Main Result

Effect estimate: Mean difference -3.21 Wood units (95% CI -4.633 to -1.785)

Absolute Event Rate: -2.41% vs 0.8%

Limitations

  • Relatively small sample size
  • Open-label design introducing potential observer or patient expectation bias
  • Short follow-up period restricting assessment of sustained efficacy and safety
  • Conducted at a single center in Japan, limiting generalizability

Abstract

Background: Acute right heart failure (RHF) is life threatening in patients with pulmonary hypertension (PH). This study investigated the efficacy and safety of inhaled nitric oxide (iNO; INOflo®for inhalation 800 ppm), a rapid pulmonary vasodilator, in patients with acute severe RHF due to PH.

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Cite This Study

Ogo et al. (2026) conducted an RCT in Acute severe right heart failure with pulmonary hypertension (n=30). Inhaled nitric oxide (iNO) vs. Control (no iNO) was evaluated on Change in pulmonary vascular resistance (PVR) from baseline to 30 minutes (Mean difference -3.21 Wood units, 95% CI -4.633 to -1.785). Inhaled nitric oxide reduced pulmonary vascular resistance by 3.21 Wood units compared to control at 30 minutes in patients with acute severe right heart failure and pulmonary hypertension.

synapsesocial.com/papers/69c0ddb8fddb9876e79c10d8https://doi.org/10.1253/circj.cj-26-0119
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