Pulmonary Arterial HypertensionNCT07214129
Safety and Efficacy of Nebulized Nitroglycerin in Pulmonary Arterial Hypertension
A study testing Nebulized nitroglycerin in people with Pulmonary Arterial Hypertension, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Nebulized nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with clinical and echocardiographic features suggestive of pulmonary hypertension after exclusion of all secondary causes.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Nebulized nitroglycerin
- Keywords
- Nebulized nitroglycerin, pulmonary arterial hypertension, vaso-reactive agent
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized nitroglycerinDrug
Also called Nitroglycerin
Nebulized nitroglycerin as vaso-reactive agen in pulmonary arterial hypertension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nebulized nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension
Nebulized nitroglycerin cause vasodilation in pulmonary arterial hypertension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214129
- Sponsor's protocol ID
- MD.22.02.608.R1
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nebulized Nitroglycerin as a Vaso-reactive Agent in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07214129
- Acronym / sponsor ID
- MD.22.02.608.R1
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Nebulized nitroglycerin, pulmonary arterial hypertension, vaso-reactive agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent | Experimental | Drug: Nebulized nitroglycerinA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients with clinical and echocardiographic features suggestive of pulmonary hypertension after exclusion of all secondary causes.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized nitroglycerinAlso: NitroglycerinNebulized nitroglycerin as vaso-reactive agen in pulmonary arterial hypertension | Drug | pulmonary arterial hypertension patients received Nebulized nitroglycerin as a vaso-reactive agent |
Primary outcome
Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension
Time frame: 6 months
Nebulized nitroglycerin cause vasodilation in pulmonary arterial hypertension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized nitroglycerin in people with Pulmonary Arterial Hypertension, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nebulized nitroglycerin as vaso-reactive agent in pulmonary arterial hypertension (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.