Pulmonary Arterial HypertensionPAH-LTXNCT02391441
Ventricular Reversed Remodeling After LTX in PAH Patients
An observational study of Pulmonary Arterial Hypertension, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Aug 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Patients with pulmonary arterial hypertension and control patients without increased pulmonary artery pressure who are on the waiting list for double-LTX
Who may be able to join
- Patients who are on the waiting list for double-LTX, in our institution, for pulmonary arterial hypertension.
- Eligible for CMR imaging
- No claustrophobia
- No pacemaker, ICD, etc.
- Informed consent
Who cannot join
- Inability to comply with primary endpoint measures.
- Body mass index ≥40 kg/m2.
- Pregnant patients will not be included, they may be included >3 months after pregnancy.
- Patients with age <18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.
Read the detailed description
In this study, pre-LTX and six-months post-LTX measurements will be compared with each other and between the primary and control group.
Pre- and post-LTX measurements include:
Past medical history: Including basic diagnosis; interventions, surgery and transplant related complications (re-operations, hospitalizations, infections) and medication history; These data will be collected by studying the medical files including surgical reports.
Present medical history: Including NYHA class.
Physical examination: Including length and weight.
Cardiac Magnetic Resonance Imaging:
- Ventricular volume, function and mass measurements
- Flow measurements of the pulmonary artery and aorta
- Disease specific measurements (e.g. septal bowing, RV trabecularisation, etc.)
- T1-mapping
Transthoracic Echocardiography
Resting ECG: Disease specific electrophysiological findings (e.g. QRS-duration, right bundle branch block).
Laboratory evaluation:
- NT-pro-BNP
- eGFR
- Remaining serum will be stored.
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary, Arterial, Hypertension, Lung, Transplantation, MRI
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension
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 |
|---|---|---|
| Pulmonary arterial hypertension | Patients who are on the waiting list for double-LTX for pulmonary arterial hypertension. | |
| Control group | Control patients without increased pulmonary artery pressure (i.e. RV peak pressure <35 mmHg measured with echocardiography) who are on the waiting list for double-LTX. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular remodeling on cardiac magnetic resonance
Absolute increase in RV ejection fraction
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Absolute increase in LV ejection fraction
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Absolute decrease in RV myocardial mass
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Absolute increase in LV myocardial mass
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Absolute decrease in RV end-diastolic volume
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Absolute increase in LV end-diastolic volume
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Restoration of septal displacement
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Decrease in RV myocardial extracellulair volume assessed with T1-mapping
Measured: Six months postoperative
Ventricular remodeling on cardiac magnetic resonance
Decrease in LV end-systolic eccentricity index
Measured: Six months postoperative
Secondary outcomes (10)
Functional remodeling patterns after LTX, assessed with echocardiography
Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)
Measured: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Increase in myocardial performance index (MPI) or Tei index
Measured: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Increase in tricuspid annular systolic motion velocity (i.e. RV s')
Measured: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Increase in RV (global/septal/free wall) longitudinal strain
Measured: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Decrease in RA size
Measured: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Increase in LA size
Measured: Six months postoperative
Change in heart failure biomarkers
Decrease in NT pro-BNP
Measured: Six months postoperative
Electrocardiographic remodeling
Normalization of RV hypertrophy and strain
Measured: Six months postoeprative
Electrocardiographic remodeling
Normalization of right axis deviation
Measured: Six months postoeprative
Electrocardiographic remodeling
Normalization of right atrial enlargement
Measured: Six months postoeprative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, J.P. van Melle, University Medical Center Groningen
- Investigators
- Dirk J van Veldhuisen, MD PhD, Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391441
- Sponsor's protocol ID
- METc2014/134
- Acronym
- PAH-LTX
- Status last verified
- Aug 2019
- First submitted
- 6 Mar 2015
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02391441
- Acronym / sponsor ID
- PAH-LTX / METc2014/134
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary, Arterial, Hypertension, Lung, Transplantation, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- Mar 2015
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 18 Mar 2015 (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.
The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.
Detailed description
In this study, pre-LTX and six-months post-LTX measurements will be compared with each other and between the primary and control group.
Pre- and post-LTX measurements include:
Past medical history: Including basic diagnosis; interventions, surgery and transplant related complications (re-operations, hospitalizations, infections) and medication history; These data will be collected by studying the medical files including surgical reports.
Present medical history: Including NYHA class.
Physical examination: Including length and weight.
Cardiac Magnetic Resonance Imaging:
- Ventricular volume, function and mass measurements
- Flow measurements of the pulmonary artery and aorta
- Disease specific measurements (e.g. septal bowing, RV trabecularisation, etc.)
- T1-mapping
Transthoracic Echocardiography
Resting ECG: Disease specific electrophysiological findings (e.g. QRS-duration, right bundle branch block).
Laboratory evaluation:
- NT-pro-BNP
- eGFR
- Remaining serum will be stored.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | –Patients who are on the waiting list for double-LTX for pulmonary arterial hypertension. |
| Control group | – | –Control patients without increased pulmonary artery pressure (i.e. RV peak pressure <35 mmHg measured with echocardiography) who are on the waiting list for double-LTX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension and control patients without increased pulmonary artery pressure who are on the waiting list for double-LTX
Key inclusion criteria (5 listed)
- Patients who are on the waiting list for double-LTX, in our institution, for pulmonary arterial hypertension.
- Eligible for CMR imaging
- No claustrophobia
- No pacemaker, ICD, etc.
- Informed consent
Key exclusion criteria (4 listed)
- Inability to comply with primary endpoint measures.
- Body mass index ≥40 kg/m2.
- Pregnant patients will not be included, they may be included >3 months after pregnancy.
- Patients with age <18 years.
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
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute increase in RV ejection fraction
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute increase in LV ejection fraction
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute decrease in RV myocardial mass
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute increase in LV myocardial mass
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute decrease in RV end-diastolic volume
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Absolute increase in LV end-diastolic volume
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Restoration of septal displacement
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Decrease in RV myocardial extracellulair volume assessed with T1-mapping
Ventricular remodeling on cardiac magnetic resonance
Time frame: Six months postoperative
Decrease in LV end-systolic eccentricity index
10 secondary outcomes
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography
Time frame: Six months postoperative
Change in heart failure biomarkers
Time frame: Six months postoperative
Electrocardiographic remodeling
Time frame: Six months postoeprative
Electrocardiographic remodeling
Time frame: Six months postoeprative
Electrocardiographic remodeling
Time frame: Six months postoeprative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
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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.
Dirk J van Veldhuisen, MD PhD study director
University Medical Center Groningen
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 Pulmonary Arterial Hypertension, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ventricular remodeling on cardiac magnetic resonance (time frame: Six months postoperative). The study lists 9 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 26 Aug 2019.