University Medical Center Groningen
Groningen, 9713GZ, Netherlands
NCT Number: NCT02391441
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.
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Notify Me18 year and older
All sexes
Observational
Groningen, 9713GZ, Netherlands
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:
Transthoracic Echocardiography
Resting ECG: Disease specific electrophysiological findings (e.g. QRS-duration, right bundle branch block).
Laboratory evaluation:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Six months postoperative
Absolute increase in RV ejection fraction
Time frame: Six months postoperative
Absolute increase in LV ejection fraction
Time frame: Six months postoperative
Absolute decrease in RV myocardial mass
Time frame: Six months postoperative
Absolute increase in LV myocardial mass
Time frame: Six months postoperative
Absolute decrease in RV end-diastolic volume
Time frame: Six months postoperative
Absolute increase in LV end-diastolic volume
Time frame: Six months postoperative
Restoration of septal displacement
Time frame: Six months postoperative
Decrease in RV myocardial extracellulair volume assessed with T1-mapping
Time frame: Six months postoperative
Decrease in LV end-systolic eccentricity index
Time frame: Six months postoperative
Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)
Time frame: Six months postoperative
Increase in myocardial performance index (MPI) or Tei index
Time frame: Six months postoperative
Increase in tricuspid annular systolic motion velocity (i.e. RV s')
Time frame: Six months postoperative
Increase in RV (global/septal/free wall) longitudinal strain
Time frame: Six months postoperative
Decrease in RA size
Time frame: Six months postoperative
Increase in LA size
Time frame: Six months postoperative
Decrease in NT pro-BNP
Time frame: Six months postoeprative
Normalization of RV hypertrophy and strain
Time frame: Six months postoeprative
Normalization of right axis deviation
Time frame: Six months postoeprative
Normalization of right atrial enlargement
Time frame: Six months postoperative
Decrease in NYHA-class
University Medical Center Groningen
Other
Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
Acronym: PAH-LTX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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