CTEPHNCT07299227
Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics
An observational study of CTEPH, run by Kerckhoff Klinik at 1 site in Germany.
Trial summary
Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CTEPH
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2025to 31 Dec 2028
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All CTEPH patients to undergo BPA
Who may be able to join
- Patient referred to BPA
- clinical indication for CMR
- capability to give informed consent
Who cannot join
- general: non-compliance, <18 years of age, pregnancy
- contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kerckhoff-Klinik
Bad Nauheim, Hesse, 61231
Markus Schönburg, MD, 06032-996-2620, m.schoenburg@kerckhoff-klinik.de
About this study
Official title: Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics
Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.
- Conditions
- CTEPH
- Keywords
- CTEPH, CMR, 4D flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTEPH patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of BPA on cardio-pulmonary vascular physiology
1a) Changes in right cardiac function (RV EF %)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
1b) Changes in cardiac function (RV GLS%)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
2a) Changes in pulmonary artery flow (peak flow m/s)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
2b) Changes in pulmonary artery flow (mean flow m/s)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
2c) Changes in pulmonary artery flow (pulse wave velocity m/s)
Measured: 1 year
Secondary outcomes (3)
Impact of BPA on cardio-pulmonary vascular physiology
1a) Change in LV tissue composition - T1 (ms)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
1b) Change in LV tissue composition - ECV (%)
Measured: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
- Change in RA phasic function (%).
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 posted23 Dec 2025
- Study start1 Sep 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEPHStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299227
- Sponsor's protocol ID
- AZ 158/24
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics
- ClinicalTrials.gov ID
- NCT07299227
- Acronym / sponsor ID
- AZ 158/24
- Conditions
- CTEPH
- Keywords
- CTEPH, CMR, 4D flow
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kerckhoff KlinikUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Dec 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 CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTEPH patient | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All CTEPH patients to undergo BPA
Key inclusion criteria (3 listed)
- Patient referred to BPA
- clinical indication for CMR
- capability to give informed consent
Key exclusion criteria (2 listed)
- general: non-compliance, <18 years of age, pregnancy
- contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
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
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
1a) Changes in right cardiac function (RV EF %)
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
1b) Changes in cardiac function (RV GLS%)
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
2a) Changes in pulmonary artery flow (peak flow m/s)
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
2b) Changes in pulmonary artery flow (mean flow m/s)
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
2c) Changes in pulmonary artery flow (pulse wave velocity m/s)
3 secondary outcomes
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
Impact of BPA on cardio-pulmonary vascular physiology
Time frame: 1 year
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 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for CTEPH
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CTEPH, run by Kerckhoff Klinik at 1 site in Germany.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Dec 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 Germany. 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?
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 Sören Jan Backhaus, MD (06032-996-2620, soeren.backhaus@outlook.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of BPA on cardio-pulmonary vascular physiology (time frame: 1 year). The study lists 5 primary outcomes in all. 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 23 Dec 2025.