Safety and Efficacy of Nebulized Nitroglycerin in Pulmonary Arterial Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Nebulized nitroglycerin

• Registration Number: NCT07214129
• Lead Sponsor: Mansoura University

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

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 Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-01
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent	Nebulized nitroglycerin	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.

Primary Outcome Measures

Name	Time	Method
Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension	6 months	Nebulized nitroglycerin cause vasodilation in pulmonary arterial hypertension

Trial Locations

Locations (1)

Mohamed AbdElmoniem; 🇪🇬 Al Mansurah, Egypt