PHTN in Scleroderma PatientsNCT07186439
Pulmonary Hypertension Screening in Scleroderma
An observational study of PHTN in Scleroderma Patients, run by Assiut University.
Trial summary
Screening for pulmonary hypertension in scleroderma patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PHTN in Scleroderma Patients
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: aga ≥18 years confirmed diagnosis of scleroderma
Who may be able to join
- . Inclusion criteria: aga ≥18 years confirmed diagnosis of scleroderma
Who cannot join
- aga <18 years
- patients refused to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Screening for pulmonary hypertension in scleroderma patients
Read the detailed description
Scleroderma is a heterogenous connective tissue disorder characterized by fibrosis of the skin, with or without internal organ involvement. The aetiology of scleroderma may involve both environmental and genetic factors. Abnormalities involving the immune system, vascular tissue and extracellular matrix have been demonstrated.
One of the major cause of mortality in patients with scleroderma is pulmonary arterial hypertension (PAH). International recommendations advise annual screening for the early detection of PAH in asymptomatic patients with scleroderma.
scleroderma is group 1 in clinical classification of pulmonary hypertension Pulmonary hypertension (PH) is a haemodynamic condition characterised by elevation of mean pulmonary arterial pressure (mPAP) >20 mmHg, assessed by right heart catheterisation. Pulmonary arterial wedge pressure (PAWP) and pulmonary vascular resistance (PVR) distinguish pre-capillary PH (PAWP ≤15 mmHg, PVR >2 Wood Units (WU)), isolated post-capillary PH (PAWP >15 mmHg, PVR ≤2 WU) and combined post- and pre-capillary PH (PAWP >15 mmHg, PVR >2 WU) Scleroderma has an annual prevalence of one to five cases for every 1000 individuals and nearly 15 percent of all cases develop PAH. A diagnosis of PAH in Scleroderma is virtually a death sentence, with studies reporting a mortality rate of 50 per cent in the 3 years of diagnosis. Therefore, developing and implementing screening and diagnosis protocol is important in the fight against this disease. echocardiography as the leading screening tool for scleroderma -PAH. In particular, systolic pulmonary arterial pressure (sPAP) and tricuspid regurgitation velocity (TRV). Echocardiography is non invasive tool for eary screening in pulmonary hypertension according ESC-ERS guideline If the peak tricuspid regurgitation velocity (TRV) is ≤ 2.8 m/s or not measurable, and there are no other echocardiographic signs of pulmonary hypertension, the probability is low.
If the TRV is ≤ 2.8 m/s or not measurable, but other echocardiographic signs of pulmonary hypertension are present, the probability is intermediate low
If the TRV is between 2.9 and 3.4 m/s and no other signs are present, the probability is intermediate high
If the TRV is between 2.9 and 3.4 m/s and other signs are present, the probability is high.
PH probability LOW → other causes . PH probability ntermediate low → follow up Echocardiography PH probability INTERMEDIATE high or HIGH → right heart catheterization Additional echocardiographic signs suggestive of pulmonary hypertension
A: The ventricles
RV/LV basal diameter area ratio ≥1.0
Flattening of the interventricular septum (LVEI >1.1 in systole and/or diastole)
TAPSE / sPAP ratio <0.55 mm/mmHg
B: Pulmonary artery
RVOT AT <105 ms and/or mid-systolic notching
Early diastolic pulmonary regurgitation velocity >2.2 m/s
PA diameter >25 mm
RPA diameter >25 mm
C: Inferior vena cava and RA
IVC diameter >21 mm with decreased inspiratory collapse (<50% with a sniff or <20% with quiet inspiration)
RA area (end-systole) >18 cm²
- Conditions
- PHTN in Scleroderma Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for pulmonary hypertension in scleroderma patients
detection rate of pulmonary hypertension in scleroderma by Echocardiography
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PHTN in Scleroderma PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Sayed Abdalazeaz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186439
- Sponsor's protocol ID
- PHTN in scleroderma
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chennakesavulu PV, Uppaluri S, Koyi J, Jhaveri S, Avanthika C, Sakhamuri LT, Ashokbhai PK, Singh P. Pulmonary Hypertension in Scleroderma- Evaluation and Management. Dis Mon. 2023 Jul;69(7):101468. doi: 10.1016/j.disamonth.2022.101468. Epub 2022 Sep 24.
PubMed 36163292Kovacs G, Bartolome S, Denton CP, Gatzoulis MA, Gu S, Khanna D, Badesch D, Montani D. Definition, classification and diagnosis of pulmonary hypertension. Eur Respir J. 2024 Oct 31;64(4):2401324. doi: 10.1183/13993003.01324-2024. Print 2024 Oct.
PubMed 39209475Brown Z, Proudman S, Morrisroe K, Stevens W, Hansen D, Nikpour M. Screening for the early detection of pulmonary arterial hypertension in patients with systemic sclerosis: A systematic review and meta-analysis of long-term outcomes. Semin Arthritis Rheum. 2021 Jun;51(3):495-512. doi: 10.1016/j.semarthrit.2021.03.011. Epub 2021 Apr 4.
PubMed 33857705Chen K, See A, Shumack S. Epidemiology and pathogenesis of scleroderma. Australas J Dermatol. 2003 Feb;44(1):1-7; quiz 8-9. doi: 10.1046/j.1440-0960.2003.06301.x.
PubMed 12581091Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.
PubMed 36017548
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension Screening in Scleroderma
- ClinicalTrials.gov ID
- NCT07186439
- Acronym / sponsor ID
- PHTN in scleroderma
- Conditions
- PHTN in Scleroderma Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 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.
Screening for pulmonary hypertension in scleroderma patients
Detailed description
Scleroderma is a heterogenous connective tissue disorder characterized by fibrosis of the skin, with or without internal organ involvement. The aetiology of scleroderma may involve both environmental and genetic factors. Abnormalities involving the immune system, vascular tissue and extracellular matrix have been demonstrated.
One of the major cause of mortality in patients with scleroderma is pulmonary arterial hypertension (PAH). International recommendations advise annual screening for the early detection of PAH in asymptomatic patients with scleroderma.
scleroderma is group 1 in clinical classification of pulmonary hypertension Pulmonary hypertension (PH) is a haemodynamic condition characterised by elevation of mean pulmonary arterial pressure (mPAP) >20 mmHg, assessed by right heart catheterisation. Pulmonary arterial wedge pressure (PAWP) and pulmonary vascular resistance (PVR) distinguish pre-capillary PH (PAWP ≤15 mmHg, PVR >2 Wood Units (WU)), isolated post-capillary PH (PAWP >15 mmHg, PVR ≤2 WU) and combined post- and pre-capillary PH (PAWP >15 mmHg, PVR >2 WU) Scleroderma has an annual prevalence of one to five cases for every 1000 individuals and nearly 15 percent of all cases develop PAH. A diagnosis of PAH in Scleroderma is virtually a death sentence, with studies reporting a mortality rate of 50 per cent in the 3 years of diagnosis. Therefore, developing and implementing screening and diagnosis protocol is important in the fight against this disease. echocardiography as the leading screening tool for scleroderma -PAH. In particular, systolic pulmonary arterial pressure (sPAP) and tricuspid regurgitation velocity (TRV). Echocardiography is non invasive tool for eary screening in pulmonary hypertension according ESC-ERS guideline If the peak tricuspid regurgitation velocity (TRV) is ≤ 2.8 m/s or not measurable, and there are no other echocardiographic signs of pulmonary hypertension, the probability is low.
If the TRV is ≤ 2.8 m/s or not measurable, but other echocardiographic signs of pulmonary hypertension are present, the probability is intermediate low
If the TRV is between 2.9 and 3.4 m/s and no other signs are present, the probability is intermediate high
If the TRV is between 2.9 and 3.4 m/s and other signs are present, the probability is high.
PH probability LOW → other causes . PH probability ntermediate low → follow up Echocardiography PH probability INTERMEDIATE high or HIGH → right heart catheterization Additional echocardiographic signs suggestive of pulmonary hypertension
A: The ventricles
RV/LV basal diameter area ratio ≥1.0
Flattening of the interventricular septum (LVEI >1.1 in systole and/or diastole)
TAPSE / sPAP ratio <0.55 mm/mmHg
B: Pulmonary artery
RVOT AT <105 ms and/or mid-systolic notching
Early diastolic pulmonary regurgitation velocity >2.2 m/s
PA diameter >25 mm
RPA diameter >25 mm
C: Inferior vena cava and RA
IVC diameter >21 mm with decreased inspiratory collapse (<50% with a sniff or <20% with quiet inspiration)
RA area (end-systole) >18 cm²
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- aga ≥18 years confirmed diagnosis of scleroderma
Key inclusion criteria (1 listed)
- . Inclusion criteria: aga ≥18 years confirmed diagnosis of scleroderma
Key exclusion criteria (2 listed)
- aga <18 years
- patients refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening for pulmonary hypertension in scleroderma patients
Time frame: baseline
detection rate of pulmonary hypertension in scleroderma by Echocardiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 36163292Chennakesavulu PV, Uppaluri S, Koyi J, Jhaveri S, Avanthika C, Sakhamuri LT, Ashokbhai PK, Singh P. Pulmonary Hypertension in Scleroderma- Evaluation and Management. Dis Mon. 2023 Jul;69(7):101468. doi: 10.1016/j.disamonth.2022.101468. Epub 2022 Sep 24.
- Background: PubMed 39209475Kovacs G, Bartolome S, Denton CP, Gatzoulis MA, Gu S, Khanna D, Badesch D, Montani D. Definition, classification and diagnosis of pulmonary hypertension. Eur Respir J. 2024 Oct 31;64(4):2401324. doi: 10.1183/13993003.01324-2024. Print 2024 Oct.
- Background: PubMed 33857705Brown Z, Proudman S, Morrisroe K, Stevens W, Hansen D, Nikpour M. Screening for the early detection of pulmonary arterial hypertension in patients with systemic sclerosis: A systematic review and meta-analysis of long-term outcomes. Semin Arthritis Rheum. 2021 Jun;51(3):495-512. doi: 10.1016/j.semarthrit.2021.03.011. Epub 2021 Apr 4.
- Background: PubMed 12581091Chen K, See A, Shumack S. Epidemiology and pathogenesis of scleroderma. Australas J Dermatol. 2003 Feb;44(1):1-7; quiz 8-9. doi: 10.1046/j.1440-0960.2003.06301.x.
- Background: PubMed 36017548Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of PHTN in Scleroderma Patients, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Sayed Abdalzeaz, Resident doctor (01093243340, esraasayedabdalzeaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening for pulmonary hypertension in scleroderma patients (time frame: baseline). 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 NCT07186439, which also lists 5 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 24 Sep 2025.