Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02391441
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2015-03-06
Brief Title:
Ventricular Reversed Remodeling After LTX in PAH Patients
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH-LTX
Brief 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 eg 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 eg septal bowing RV trabecularisation etc
T1-mapping
Transthoracic Echocardiography
Resting ECG Disease specific electrophysiological findings eg QRS-duration right bundle branch block
Laboratory evaluation
NT-pro-BNP
eGFR
Remaining serum will be stored
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 eg septal bowing RV trabecularisation etc
T1-mapping
Transthoracic Echocardiography
Resting ECG Disease specific electrophysiological findings eg QRS-duration right bundle branch block
Laboratory evaluation
NT-pro-BNP
eGFR
Remaining serum will be stored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None