Pulmonary HypertensionPhase 3NCT02791282
CTEPH DIAGNOSIS Europe - MRI
A Phase 3 study testing Index test: functional dynamic contrast enhanced (DCE)-MRI in people with Pulmonary Hypertension, run by Hannover Medical School at 1 site in Germany.
Trial summary
Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Index test: functional dynamic contrast enhanced (DCE)-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Jun 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transthoracic echocardiography indicates pulmonary hypertension
- Patients with clinical suspicion for CTEPH, scheduled for SPECT
- Provided informed consent for the study
- Age >18y
Who cannot join
- Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
- Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Jens Vogel-Claussen, MD, +49 5115323421, vogel-claussen.jens@mh-hannover.de
About this study
Official title: CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)
Read the detailed description
CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.
- Conditions
- Pulmonary Hypertension
- Being tested
- Index test: functional dynamic contrast enhanced (DCE)-MRI
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), MRI, SPECT
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index test: functional dynamic contrast enhanced (DCE)-MRIOther
Index test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months
| Study group | Role | What they receive |
|---|---|---|
| Index test: functional dynamic contrast enhanced (DCE)-MRI | Other | Patients with clinical suspicion for CTEPH, scheduled for SPECT Receives: Other: Index test: functional dynamic contrast enhanced (DCE)-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard
Measured: 6 months
The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
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 posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (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.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Giessen, Ludwig-Maximilians - University of Munich, Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Jens Vogel-Claussen, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791282
- Sponsor's protocol ID
- CHANGE-MRI
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Klein MM, Voskrebenzev A, Klimes F, Speth M, Muller RA, Olsson KM, Glandorf J, Heussel CP, Grunig E, Gall H, Ghofrani A, Roller F, Harth S, Marshall H, Hughes PJC, Swift AJ, Kiely DG, Behr J, Dinkel J, Beitzke D, Lang IM, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Wild J, Vogel-Claussen J. Phase-Resolved Functional Lung MRI-derived Pulmonary Arterial Pulse Wave Velocity Correlates with 12-Month Mortality in Participants with Pulmonary Hypertension: A Post Hoc Analysis of a Multicenter Study. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250508. doi: 10.1148/ryct.250508.
PubMed 42622518Lasch F, Karch A, Koch A, Derlin T, Voskrebenzev A, Alsady TM, Hoeper MM, Gall H, Roller F, Harth S, Steiner D, Krombach G, Ghofrani HA, Rengier F, Heussel CP, Grunig E, Beitzke D, Hacker M, Lang IM, Behr J, Bartenstein P, Dinkel J, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Pfeifer M, Johns CS, Kiely DG, Swift AJ, Wild J, Vogel-Claussen J. Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. Front Cardiovasc Med. 2020 Apr 9;7:51. doi: 10.3389/fcvm.2020.00051. eCollection 2020.
PubMed 32328500
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
- ClinicalTrials.gov ID
- NCT02791282
- Acronym / sponsor ID
- CHANGE-MRI
- Conditions
- Pulmonary Hypertension
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), MRI, SPECT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- University of Sheffield, University of Giessen, Ludwig-Maximilians - University of Munich, Heidelberg University
- Study start
- May 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- 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.
Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)
Detailed description
CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Index test: functional dynamic contrast enhanced (DCE)-MRI | Other | Other: Index test: functional dynamic contrast enhanced (DCE)-MRIPatients with clinical suspicion for CTEPH, scheduled for SPECT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Transthoracic echocardiography indicates pulmonary hypertension
- Patients with clinical suspicion for CTEPH, scheduled for SPECT
- Provided informed consent for the study
- Age >18y
Key exclusion criteria (2 listed)
- Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
- Women who are pregnant or breast feeding
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 |
|---|---|---|
| Index test: functional dynamic contrast enhanced (DCE)-MRIIndex test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months | Other | Index test: functional dynamic contrast enhanced (DCE)-MRI |
Primary outcome
The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard
Time frame: 6 months
The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Derived from this study: PubMed 42622518Klein MM, Voskrebenzev A, Klimes F, Speth M, Muller RA, Olsson KM, Glandorf J, Heussel CP, Grunig E, Gall H, Ghofrani A, Roller F, Harth S, Marshall H, Hughes PJC, Swift AJ, Kiely DG, Behr J, Dinkel J, Beitzke D, Lang IM, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Wild J, Vogel-Claussen J. Phase-Resolved Functional Lung MRI-derived Pulmonary Arterial Pulse Wave Velocity Correlates with 12-Month Mortality in Participants with Pulmonary Hypertension: A Post Hoc Analysis of a Multicenter Study. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250508. doi: 10.1148/ryct.250508.
- Derived from this study: PubMed 32328500Lasch F, Karch A, Koch A, Derlin T, Voskrebenzev A, Alsady TM, Hoeper MM, Gall H, Roller F, Harth S, Steiner D, Krombach G, Ghofrani HA, Rengier F, Heussel CP, Grunig E, Beitzke D, Hacker M, Lang IM, Behr J, Bartenstein P, Dinkel J, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Pfeifer M, Johns CS, Kiely DG, Swift AJ, Wild J, Vogel-Claussen J. Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. Front Cardiovasc Med. 2020 Apr 9;7:51. doi: 10.3389/fcvm.2020.00051. eCollection 2020.
- study websiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Jens Vogel-Claussen, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Index test: functional dynamic contrast enhanced (DCE)-MRI in people with Pulmonary Hypertension, run by Hannover Medical School 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2016. 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.
What does this phase mean?
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?
Contact Jens Vogel-Claussen, MD (+49 511 5323421, vogel-claussen.jens@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02791282, 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 6 Jun 2016.