Safety and Efficacy of Nebulized Nitroglycerin in Pulmonary Arterial Hypertension

October 2, 2025 updated by: Mansoura University

Safety and Efficacy of Nebulized Nitroglycerin as a Vaso-reactive Agent in Pulmonary Arterial Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Right Heart Catheterization (RHC) is the diagnostic gold standard for pulmonary hypertension (PH), In fact, RHC is the definitive diagnostic technique for reliably confirming whether a patient has PAH .In addition to its use in diagnosis, RHC provides useful information on the degree of hemodynamic impairment, determines response to PAH therapy and establishes prognosis, thereby informing clinical decision-making in the management of PAH. Acute vaso-reactivity test (AVT) is defined as "a fall of at least 10 mmHg in mean pulmonary artery pressure (PAP); a fall to an absolute mean PAP less than 40 mmHg; and unchanged or increased cardiac output". AVT is typically performed with a short-acting agent such as inhaled nitric oxide, inhaled iloprost, intravenous epoprostenol, or adenosine. Baseline hemodynamic measurements are obtained prior to testing. AVT is performed for three reasons in pulmonary hypertension (PH): 1) identification of patients who may display a favorable long-term response to calcium channel blocker treatment, 2) gathering prognostic information,3) scientific research purposes.

The aim of this study is to evaluate the safety and efficacy of nebulized nitroglycerin as a vaso-reactive agent in pulmonary arterial hypertension.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt, 35516
        • Mohamed AbdElmoniem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All adult patients with clinical and echocardiographic features suggestive of pulmonary hypertension after exclusion of all secondary causes.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent

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
Nebulized nitroglycerin as vaso-reactive agen in pulmonary arterial hypertension
Other Names:
  • Nitroglycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension
Time Frame: 6 months
Nebulized nitroglycerin cause vasodilation in pulmonary arterial hypertension
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

October 2, 2025

First Submitted That Met QC Criteria

October 2, 2025

First Posted (Estimated)

October 9, 2025

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.22.02.608.R1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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