Chronic Thromboembolic Pulmonary HypertensionPhase 2/3BPA-PADNNCT06209710
Balloon Pulmonary Angioplasty vs. Combined Approach With Pulmonary Artery Denervation in CTEPH: Effectiveness Comparison
A Phase 2/3 study testing Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation in people with Chronic Thromboembolic Pulmonary Hypertension, run by Boris Dzudovic at 1 site in Serbia.
Trial summary
This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated blood clots in the lungs, leading to increased pressure and strain on the heart. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Apr 2024to Dec 2025
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age 18 - 80 years.
- Diagnosis of chronic thromboembolic heart disease.
- Mean pulmonary arterial pressure (mPAP) >20 mmHg.
- Pulmonary vascular resistance >3 Wood units.
- Presence of organized thrombus masses.
- World Health Organization (WHO) functional class II to IV.
Who cannot join
- Proximal organized thrombotic masses not suitable for Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN).
- WHO functional class I
- Additionally, participants can be excluded from the trial under the following circumstances:
- Withdrawal of consent at any time.
- Failure to complete the treatment as per protocols.
- Protocol violations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effectiveness of Balloon Pulmonary Angioplasty Alone vs. Combined With Pulmonary Artery Denervation in Chronic Thromboembolic Pulmonary Hypertension Patients Receiving Standard Medical Therapy
This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated blood clots in the lungs, leading to increased pressure and strain on the heart. The study aims to assess the effectiveness of combining two treatments, balloon pulmonary angioplasty (BPA) and pulmonary artery denervation (PADN), in reducing blood pressure in the lungs compared to the standard treatment. Additionally, the trial will explore the impact of these treatments on patients' quality of life. The hope is to improve outcomes and provide valuable insights into managing this challenging condition.
Read the detailed description
This clinical trial focuses on advancing our understanding and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH arises when blood clots in the lungs fail to fully dissolve, leading to the formation of fibrous masses that obstruct blood vessels, increase pulmonary blood pressure, and strain the heart's right ventricle.
The study's primary objective is to evaluate the combined use of two innovative treatments, Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), in comparison to the standard treatment for CTEPH. BPA involves using a balloon to open narrowed or blocked pulmonary arteries, while PADN is a novel therapy targeting nerve clusters near the main pulmonary artery to reduce blood pressure.
The trial also aims to assess the impact of these treatments on patients' quality of life and clinical improvement measured through the 6-Minute Walk Test Distance (6-MWTD) and the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaires.In addition to evaluating the combined efficacy of BPA and PADN compared to standard treatment, this clinical trial has a specific objective to customize the PADN intervention based on individual patient characteristics. The study aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN, considering the pulmonary artery size or diameter. This innovative approach seeks to tailor the intervention to the unique anatomical features of each patient, enhancing the precision and effectiveness of the treatment strategy.
The study design is a randomized parallel cohort study involving patients with CTEPH in phases 2/3. Patients are divided into two groups-intervention and control-and receive distinct treatment protocols. The intervention group undergoes a combination of BPA, PADN, and standard drug therapy, while the control group receives BPA, sham PADN intervention and standard drug therapy.
The BPA procedure involves accessing the pulmonary artery through the right femoral vein, measuring pressures, and selectively dilating stenosed or occluded branches. After the BPA procedure, PADN is performed by applying radiofrequency energy near the bifurcation of the main pulmonary artery.The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy.
The study includes detailed criteria for patient inclusion and exclusion, and patients are closely monitored through scheduled face-to-face visits. The trial plans to enroll approximately 20 patients.
Data management ensures the confidentiality of patient information, and analysis includes a descriptive approach and comparison of mPAP reduction after three months.
The study follows ethical guidelines, Good Clinical Practice, and recommendations from the European Association of Cardiology. Informed consent is a crucial aspect, and patient safety is paramount throughout the trial.
The trial's ultimate goal is to contribute valuable insights into the efficacy of combining BPA and PADN as a potential treatment strategy for CTEPH, aiming to improve patient outcomes and enhance our approach to managing this complex condition.
- Being tested
- Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation, Balloon Pulmonary Angioplasty with Sham Pulmonary Artery Denervation
- Keywords
- Balloon pulmonary angioplasty, Pulmonary artery denervation, CTEPH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Pulmonary Angioplasty combined with Pulmonary Artery DenervationProcedure or surgery
Participants in the intervention arm will undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), as part of this phase 2/3 clinical trial. The trial aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN based on pulmonary artery size or diameter. The BPA procedure addresses segmental and subsegmental thrombi masses through pulmonary artery dilation, while the PADN procedure involves the placement of a denervation catheter near the bifurcation of the main pulmonary artery. RF energy is selectively applied, and ablation points are determined based on individual patient characteristics and expected therapeutic effects. This unique approach seeks to customize the intervention to the patient's specific pulmonary anatomy, contributing to the overall effectiveness of the treatment strategy.
Balloon Pulmonary Angioplasty with Sham Pulmonary Artery DenervationProcedure or surgery
Participants receive Balloon Pulmonary Angioplasty (BPA) combined with a sham Pulmonary Artery Denervation (PADN) procedure. The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: BPA + PADN + Standard Drug Therapy | Experimental | Participants in this arm will undergo the combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) procedures. Receives: Procedure: Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation |
| Control Arm: BPA + Sham PADN + Standard Drug Therapy | Sham comparator | Participants in this arm will receive the combination of Balloon Pulmonary Angioplasty (BPA) and standard drug therapy as the control group. Similar to the intervention arm, a denervation catheter will be placed in the same anatomical position, but no further denervation intervention will be performed. Receives: Procedure: Balloon Pulmonary Angioplasty with Sham Pulmonary Artery Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Pulmonary Arterial Pressure (mPAP)
Measure the change in mPAP from baseline to 3 months post-intervention to assess the effectiveness of the combined BPA and PADN therapy.
Measured: 3 months
Secondary outcomes (5)
Quality of Life Assessment
Measure: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Questionnaire.
Scale: Units on a scale.
Scale Details: CAMPHOR consists of three sections:
Symptoms (Impairment) Scale (0-25): Higher scores indicate a greater extent of symptoms experienced by the patient.
Activities (Disability) Scale (0-30): Higher scores indicate more significant limitations in performing daily activities affected by chronic thromboembolic pulmonary hypertension.
Quality of Life Scale (0-25): Higher scores reflect a greater impact of the condition on various aspects of the patient's overall quality of life.
Measured: 3 months, and 1 year
Physical Functionality Assessment
Measure: 6-Minute Walk Test Distance (6-MWTD). Unit of Measure: Meters. Description: The 6-Minute Walk Test evaluates the physical functional capacity of patients with CTEPH. It measures the total distance covered by patients in a six-minute period, providing insight into their exercise tolerance and overall physical performance.
Measured: 3 months, and 1 year
Hemodynamic Response Assessment
Measure: Mean Pulmonary Arterial Pressure (mPAP) change. Unit of Measure: mmHg. Description: Assesses mPAP reduction after 1 year
Measured: 1 year
Adverse Events
Measure: Number of Participants with Documented and Categorized Adverse Events, Including Intensity and Type (e.g., cardiovascular events, bleeding events, procedural complications), to Evaluate Safety.
Measured: 3 months, abd 1 year
Survival Rates
Monitor one-year survival rate to provide insights into the long-term outcomes of the intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Patients assigned to this group undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) alongside standard drug therapy. Control Group: Patients in this group receive Balloon Pulmonary Angioplasty (BPA), Sham Pulmonary Denervation and standard drug therapy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boris Dzudovic
- Sponsor type
- University, hospital or other
- Collaborators
- Military Medical Academy, Belgrade, Serbia, Galen Research
- Responsible party
- Sponsor-investigator, Boris Dzudovic, Military Medical Academy, Belgrade, Serbia
- Investigators
- Slobodan Obradovic, MD, PhD, Principal investigator, Clinic of Cardiology, Military Medical Academy, Belgrade, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209710
- Sponsor's protocol ID
- 65/2023
- Acronym
- BPA-PADN
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to share de-identified individual participant data, excluding any personally identifiable information (PII), to protect participant privacy. Data sharing is planned to commence after the completion of the trial and the release of the main study results. The exact timing for data sharing will be in compliance with regulatory requirements and ethical considerations. Access to the shared data will be granted to researchers who submit formal requests outlining their research objectives, methodologies, and plans for data usage. A data sharing agreement will be established to ensure adherence to ethical standards and protection of participant confidentiality. Data will be shared in a standardized and machine-readable format, allowing for compatibility with various statistical analysis tools and software. The study team is committed to providing necessary documentation and support to facilitate the appropriate use and interpretation of the shared data.
Publications
Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.
PubMed 23850902Zhang H, Wei Y, Zhang C, Yang Z, Kan J, Gu H, Fan F, Gu H, Wang Q, Xie D, Zhang G, Guo X, Yin Y, Jin B, Zhou H, Yang Z, Wang Z, Xin Y, Zhang C, Meng L, Wang X, Sun J, Zhao C, Zhang J, Yan X, Chen F, Yao C, Stone GW, Chen SL. Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2412-2423. doi: 10.1016/j.jcin.2022.09.013. Epub 2022 Sep 18.
PubMed 36121246
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Balloon Pulmonary Angioplasty Alone vs. Combined With Pulmonary Artery Denervation in Chronic Thromboembolic Pulmonary Hypertension Patients Receiving Standard Medical Therapy
- ClinicalTrials.gov ID
- NCT06209710
- Acronym / sponsor ID
- BPA-PADN / 65/2023
- Keywords
- Balloon pulmonary angioplasty, Pulmonary artery denervation, CTEPH
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Boris DzudovicUniversity, hospital or other
- Collaborators
- Military Medical Academy, Belgrade, Serbia, Galen Research
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated blood clots in the lungs, leading to increased pressure and strain on the heart. The study aims to assess the effectiveness of combining two treatments, balloon pulmonary angioplasty (BPA) and pulmonary artery denervation (PADN), in reducing blood pressure in the lungs compared to the standard treatment. Additionally, the trial will explore the impact of these treatments on patients' quality of life. The hope is to improve outcomes and provide valuable insights into managing this challenging condition.
Detailed description
This clinical trial focuses on advancing our understanding and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH arises when blood clots in the lungs fail to fully dissolve, leading to the formation of fibrous masses that obstruct blood vessels, increase pulmonary blood pressure, and strain the heart's right ventricle.
The study's primary objective is to evaluate the combined use of two innovative treatments, Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), in comparison to the standard treatment for CTEPH. BPA involves using a balloon to open narrowed or blocked pulmonary arteries, while PADN is a novel therapy targeting nerve clusters near the main pulmonary artery to reduce blood pressure.
The trial also aims to assess the impact of these treatments on patients' quality of life and clinical improvement measured through the 6-Minute Walk Test Distance (6-MWTD) and the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaires.In addition to evaluating the combined efficacy of BPA and PADN compared to standard treatment, this clinical trial has a specific objective to customize the PADN intervention based on individual patient characteristics. The study aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN, considering the pulmonary artery size or diameter. This innovative approach seeks to tailor the intervention to the unique anatomical features of each patient, enhancing the precision and effectiveness of the treatment strategy.
The study design is a randomized parallel cohort study involving patients with CTEPH in phases 2/3. Patients are divided into two groups-intervention and control-and receive distinct treatment protocols. The intervention group undergoes a combination of BPA, PADN, and standard drug therapy, while the control group receives BPA, sham PADN intervention and standard drug therapy.
The BPA procedure involves accessing the pulmonary artery through the right femoral vein, measuring pressures, and selectively dilating stenosed or occluded branches. After the BPA procedure, PADN is performed by applying radiofrequency energy near the bifurcation of the main pulmonary artery.The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy.
The study includes detailed criteria for patient inclusion and exclusion, and patients are closely monitored through scheduled face-to-face visits. The trial plans to enroll approximately 20 patients.
Data management ensures the confidentiality of patient information, and analysis includes a descriptive approach and comparison of mPAP reduction after three months.
The study follows ethical guidelines, Good Clinical Practice, and recommendations from the European Association of Cardiology. Informed consent is a crucial aspect, and patient safety is paramount throughout the trial.
The trial's ultimate goal is to contribute valuable insights into the efficacy of combining BPA and PADN as a potential treatment strategy for CTEPH, aiming to improve patient outcomes and enhance our approach to managing this complex condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group: Patients assigned to this group undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) alongside standard drug therapy. Control Group: Patients in this group receive Balloon Pulmonary Angioplasty (BPA), Sham Pulmonary Denervation and standard drug therapy.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: BPA + PADN + Standard Drug Therapy | Experimental | Procedure: Balloon Pulmonary Angioplasty combined with Pulmonary Artery DenervationParticipants in this arm will undergo the combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) procedures. |
| Control Arm: BPA + Sham PADN + Standard Drug Therapy | Sham comparator | Procedure: Balloon Pulmonary Angioplasty with Sham Pulmonary Artery DenervationParticipants in this arm will receive the combination of Balloon Pulmonary Angioplasty (BPA) and standard drug therapy as the control group. Similar to the intervention arm, a denervation catheter will be placed in the same anatomical position, but no further denervation intervention will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent.
- Age 18 - 80 years.
- Diagnosis of chronic thromboembolic heart disease.
- Mean pulmonary arterial pressure (mPAP) >20 mmHg.
- Pulmonary vascular resistance >3 Wood units.
Key exclusion criteria (6 listed)
- Proximal organized thrombotic masses not suitable for Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN).
- WHO functional class I
- Additionally, participants can be excluded from the trial under the following circumstances:
- Withdrawal of consent at any time.
- Failure to complete the treatment as per protocols.
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 |
|---|---|---|
| Balloon Pulmonary Angioplasty combined with Pulmonary Artery DenervationParticipants in the intervention arm will undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), as part of this phase 2/3 clinical trial. The trial aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN based on pulmonary artery size or diameter. The BPA procedure addresses segmental and subsegmental thrombi masses through pulmonary artery dilation, while the PADN procedure involves the placement of a denervation catheter near the bifurcation of the main pulmonary artery. RF energy is selectively applied, and ablation points are determined based on individual patient characteristics and expected therapeutic effects. This unique approach seeks to customize the intervention to the patient's specific pulmonary anatomy, contributing to the overall effectiveness of the treatment strategy. | Procedure or surgery | Intervention Arm: BPA + PADN + Standard Drug Therapy |
| Balloon Pulmonary Angioplasty with Sham Pulmonary Artery DenervationParticipants receive Balloon Pulmonary Angioplasty (BPA) combined with a sham Pulmonary Artery Denervation (PADN) procedure. The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy | Procedure or surgery | Control Arm: BPA + Sham PADN + Standard Drug Therapy |
Primary outcome
Change in mean Pulmonary Arterial Pressure (mPAP)
Time frame: 3 months
Measure the change in mPAP from baseline to 3 months post-intervention to assess the effectiveness of the combined BPA and PADN therapy.
5 secondary outcomes
Quality of Life Assessment
Time frame: 3 months, and 1 year
Physical Functionality Assessment
Time frame: 3 months, and 1 year
Hemodynamic Response Assessment
Time frame: 1 year
Adverse Events
Time frame: 3 months, abd 1 year
Survival Rates
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 23850902Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.
- Background: PubMed 36121246Zhang H, Wei Y, Zhang C, Yang Z, Kan J, Gu H, Fan F, Gu H, Wang Q, Xie D, Zhang G, Guo X, Yin Y, Jin B, Zhou H, Yang Z, Wang Z, Xin Y, Zhang C, Meng L, Wang X, Sun J, Zhao C, Zhang J, Yan X, Chen F, Yao C, Stone GW, Chen SL. Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2412-2423. doi: 10.1016/j.jcin.2022.09.013. Epub 2022 Sep 18.
- Individual participant dataSharing planned: Yes. We intend to share de-identified individual participant data, excluding any personally identifiable information (PII), to protect participant privacy. Data sharing is planned to commence after the completion of the trial and the release of the main study results. The exact timing for data sharing will be in compliance with regulatory requirements and ethical considerations. Access to the shared data will be granted to researchers who submit formal requests outlining their research objectives, methodologies, and plans for data usage. A data sharing agreement will be established to ensure adherence to ethical standards and protection of participant confidentiality. Data will be shared in a standardized and machine-readable format, allowing for compatibility with various statistical analysis tools and software. The study team is committed to providing necessary documentation and support to facilitate the appropriate use and interpretation of the shared data.
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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.
Slobodan Obradovic, MD, PhD principal investigator
Clinic of Cardiology, Military Medical Academy, Belgrade, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation in people with Chronic Thromboembolic Pulmonary Hypertension, run by Boris Dzudovic at 1 site in Serbia.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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 Serbia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in mean Pulmonary Arterial Pressure (mPAP) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209710, which also lists 2 linked publications.
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 2 Apr 2024.