Pulmonary HypertensionNCT07052968
Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient
An observational study of Pulmonary Hypertension and Chronic Kidney Disease, run by Assiut University.
Trial summary
Patients with CKD who suspected to have pulmonary hypertension by echocardiography with high probability, RHC used to confirm the diagnosis, assessment of hemodynamic parameters, differentiate pre and post capillary types of pulmonary hypertension and asses severity of the disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Chronic Kidney Disease
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Admitted patients in Internal medicine department, Critical care unit and pulmonary hypertension unit chest department at Assuit University Hospital.
Who may be able to join
- All adult (aged 18 years old and older) patients who were diagnosed CKD(The presence of kidney damage or an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m², persisting for 3 months or more) and suspected to have pulmonary hypertension by clinical feature or by echocardiography with high probability were included in this study.
Who cannot join
- • Patients under 18 years old
- Patient with chronic chest disease.
- Patient bleeding diathesis and high risk of bleeding.
- Individuals having acute kidney injury.
- Patient developing other PH aetiologies.
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
Patients with CKD who suspected to have pulmonary hypertension by echocardiography with high probability, RHC used to confirm the diagnosis, assessment of hemodynamic parameters, differentiate pre and post capillary types of pulmonary hypertension and asses severity of the disease.
Read the detailed description
Pulmonary Hypertension (PH ) is a haemodynamic and pathophysiological condition characterized by an increase in mean pulmonary arterial pressure ≥ 20 mmHg at rest, measured by right heart catheterization [1]. It results from various etiologies and multifactorial mechanisms. PH is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) .
CKD is defined as abnormalities in kidney structure or function persisting for more than three months, with implications for health. The latest KDIGO guidelines classify CKD based on glomerular filtration rate and albuminuria categories [2]. CKD has systemic complications a cardiovascular and pulmonary vascular disorders.
The PH in CKD patients is multifactorial, involving volume overload, endothelial dysfunction, vascular calcification, and increased left sided pressures [3].
Echocardiography is the primary non-invasive tool for assessing PH . It estimates systolic pulmonary artery pressure and evaluates right ventricular structure and function . Although widely accessible, ECHO has limitations ;operator dependency and potential underestimation or overestimation of pressures [4]. ESC/ERS guidelines for pulmonary hypertension in assessing the probablity (6) as :
High probability: TRV >3.4 m/s or TRV 2.9-3.4 m/s with other echo PH signs Intermediate probability: TRV 2.9-3.4 m/s without other echo PH signs Low probability: TRV ≤2.8 m/s and no other PH signs. Right heart catheterization (RHC) remains the gold standard for definitive PH diagnosis. It provides direct hemodynamic measurements, distinguishing pre-capillary from post-capillary PH. RHC is crucial for guiding targeted therapy and risk stratification, ensuring accurate management in CKD patients with suspected PH (5).
- Conditions
- Pulmonary Hypertension, Chronic Kidney Disease
- Being tested
- Echocardiography
- Medical subject headings
- Hypertension, Pulmonary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Echocardiography is the non invasvive interventional assessment and the RHC is the invasive international assessment of the hemodynamics in PH patients with ckd.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management.
Hemodynamic assessment by echo including (right atrial surface area, right ventricular diameters, tricuspid annular plane systolic excursion ,tricusped regureg Jet velocity, inferior vena cava diameter and inspiratory collapability, estimated pulmonary artery pressure and left ventricular structure and function) and Hemodynamic assessment by RHC to diagnose and identify tyoe of PH according theses parameters a mean pulmonary arterial pressure (mPAP) >20 mm Hg, pulmonary artery wedge pressure (PAWP) ≤15mmHg and a PVR > 2WU. Pre-capillary PH ,mPAP >20 mmHg,PAWP ≤15mmHg,PVR ≥3WU.Isolated post-capillary PH (IpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR <3WU. Combined pre- and post-capillary PH (CpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR ≥3WU.Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test, correlations and regression tests, paired t-test will be
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (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 Pulmonary HypertensionStudies 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
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Ahmed Sarhan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052968
- Sponsor's protocol ID
- RHC in PH pts e ckd
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jankowich M, Hebel R, Jantz J, Abbasi S, Choudhary G. Multispecialty pulmonary hypertension clinic in the VA. Pulm Circ. 2017 Oct-Dec;7(4):758-767. doi: 10.1177/2045893217726063. Epub 2017 Aug 22.
PubMed 28770656Pugh ME, Hemnes AR, Trammell A, Newman JH, Robbins IM. Variability in hemodynamic evaluation of pulmonary hypertension at large referral centers. Pulm Circ. 2014 Dec;4(4):679-84. doi: 10.1086/678514.
PubMed 25610603
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient
- ClinicalTrials.gov ID
- NCT07052968
- Acronym / sponsor ID
- RHC in PH pts e ckd
- Conditions
- Pulmonary Hypertension, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jul 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.
Patients with CKD who suspected to have pulmonary hypertension by echocardiography with high probability, RHC used to confirm the diagnosis, assessment of hemodynamic parameters, differentiate pre and post capillary types of pulmonary hypertension and asses severity of the disease.
Detailed description
Pulmonary Hypertension (PH ) is a haemodynamic and pathophysiological condition characterized by an increase in mean pulmonary arterial pressure ≥ 20 mmHg at rest, measured by right heart catheterization [1]. It results from various etiologies and multifactorial mechanisms. PH is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) .
CKD is defined as abnormalities in kidney structure or function persisting for more than three months, with implications for health. The latest KDIGO guidelines classify CKD based on glomerular filtration rate and albuminuria categories [2]. CKD has systemic complications a cardiovascular and pulmonary vascular disorders.
The PH in CKD patients is multifactorial, involving volume overload, endothelial dysfunction, vascular calcification, and increased left sided pressures [3].
Echocardiography is the primary non-invasive tool for assessing PH . It estimates systolic pulmonary artery pressure and evaluates right ventricular structure and function . Although widely accessible, ECHO has limitations ;operator dependency and potential underestimation or overestimation of pressures [4]. ESC/ERS guidelines for pulmonary hypertension in assessing the probablity (6) as :
High probability: TRV >3.4 m/s or TRV 2.9-3.4 m/s with other echo PH signs Intermediate probability: TRV 2.9-3.4 m/s without other echo PH signs Low probability: TRV ≤2.8 m/s and no other PH signs. Right heart catheterization (RHC) remains the gold standard for definitive PH diagnosis. It provides direct hemodynamic measurements, distinguishing pre-capillary from post-capillary PH. RHC is crucial for guiding targeted therapy and risk stratification, ensuring accurate management in CKD patients with suspected PH (5).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients in Internal medicine department, Critical care unit and pulmonary hypertension unit chest department at Assuit University Hospital.
Key inclusion criteria (1 listed)
- All adult (aged 18 years old and older) patients who were diagnosed CKD(The presence of kidney damage or an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m², persisting for 3 months or more) and suspected to have pulmonary hypertension by clinical feature or by echocardiography with high probability were included in this study.
Key exclusion criteria (5 listed)
- • Patients under 18 years old
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 |
|---|---|---|
| EchocardiographyEchocardiography is the non invasvive interventional assessment and the RHC is the invasive international assessment of the hemodynamics in PH patients with ckd. | Device | – |
Primary outcome
Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management.
Time frame: One year
Hemodynamic assessment by echo including (right atrial surface area, right ventricular diameters, tricuspid annular plane systolic excursion ,tricusped regureg Jet velocity, inferior vena cava diameter and inspiratory collapability, estimated pulmonary artery pressure and left ventricular structure and function) and Hemodynamic assessment by RHC to diagnose and identify tyoe of PH according theses parameters a mean pulmonary arterial pressure (mPAP) >20 mm Hg, pulmonary artery wedge pressure (PAWP) ≤15mmHg and a PVR > 2WU. Pre-capillary PH ,mPAP >20 mmHg,PAWP ≤15mmHg,PVR ≥3WU.Isolated post-capillary PH (IpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR <3WU. Combined pre- and post-capillary PH (CpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR ≥3WU.Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test, correlations and regression tests, paired t-test will be
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 8 Jul 2025.
- Results publication: PubMed 28770656Jankowich M, Hebel R, Jantz J, Abbasi S, Choudhary G. Multispecialty pulmonary hypertension clinic in the VA. Pulm Circ. 2017 Oct-Dec;7(4):758-767. doi: 10.1177/2045893217726063. Epub 2017 Aug 22.
- Results publication: PubMed 25610603Pugh ME, Hemnes AR, Trammell A, Newman JH, Robbins IM. Variability in hemodynamic evaluation of pulmonary hypertension at large referral centers. Pulm Circ. 2014 Dec;4(4):679-84. doi: 10.1086/678514.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Chronic Kidney Disease, 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 5 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 8 Jul 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 Randa Ahmed, MD (+201118683728, randasarhan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management. (time frame: One year). 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 NCT07052968, 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 8 Jul 2025.