Safety and Efficacy of Nebulized Nitroglycerin in Pulmonary Arterial Hypertension

NCT07214129 | Completed

• 1 other identifier: MD.22.02.608.R1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The 6th World Symposium on Pulmonary Hypertension, pre-capillary pulmonary hypertension (PH) has been defined as mean pulmonary arterial pressure (mPAP) \>20 mm Hg with a pulmonary arterial wedge pressure (PAWP) ≤15 mm Hg and pulmonary vascular resistance (PVR) ≥3 Wood units (WU). The current classification of PH categorizes clinical conditions associated with PH based on similar pathophysiology, etiologies, clinical presentation, hemodynamic characteristics and therapeutic management. PH is classified into five groups. The group 1 pulmonary arterial hypertension (PAH), which comprises of diverse diseases that result in similar pathological changes within the pulmonary vasculature. This includes idiopathic, familial, drug and toxin induced PAH and associated forms of PAH like systemic sclerosis, portal hypertension, congenital heart disease and human immunodeficiency virus (HIV). The remaining 4 groups of PH are secondary to other conditions and are usually referred to as secondary PH

Conditions

Pulmonary Arterial Hypertension

Keywords

Nebulized nitroglycerin; pulmonary arterial hypertension; vaso-reactive agent

Outcome Measures

Primary Outcomes (1)

• Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension

  Nebulized nitroglycerin cause vasodilation in pulmonary arterial hypertension

  6 months

Study Arms (1)

pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent

EXPERIMENTAL

A local anesthetic is administered subcutaneously at the access site. Venous access is obtained with or without ultrasound guidance. Once venous access is obtained, an appropriately sized sheath is placed in the vein and secured. The pulmonary artery catheter is advanced through the sheath into the vein. The balloon is inflated after the catheter is advanced to roughly 15 cm so to avoid inflating it within the access sheath. Balloon inflation will then make advancing the catheter to the right atrium much easier. The catheter movement will be monitored by changes in wave forms or observed using fluoroscopy. Prior to recording pressures, a reference will be established by zeroing the system. Zeroing involves opening the air-fluid transducer to air so that it equilibrates with atmospheric pressure. After obtaining hemodynamic data, nitroglycerin inhalation will be given at dose 5 mg via nebulizer device over 15 minutes then reassessment will be carried out.

Drug: Nebulized nitroglycerin

Interventions

Nebulized nitroglycerin DRUG

Nebulized nitroglycerin as vaso-reactive agen in pulmonary arterial hypertension

Also known as: Nitroglycerin

pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• groups 2,3,4,5 Pulmonary hypertension
• Hemodynamic instability.
• Absolute contraindications to pulmonary artery catheter (PAC) placement include: Infection at the insertion site The presence of a right ventricular assist device Insertion during cardiopulmonary bypass Lack of consent
• Relative contraindications to the placement of a PAC include a coagulopathy (international normalized ratio \>1.5), thrombocytopenia (platelet count \<50,000/microL), electrolyte disturbances (hypo- or hyper-kalemia, -magnesemia, -natremia, -calcemia), and severe acid-base disturbances (eg, pH \<7.2 or \>7.5).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Mohamed AbdElmoniem

  Lecturer of chest medicine faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

EG (1)