Clinical trial NCT02391441: Ventricular Reversed Remodeling After LTX in PAH Patients
Official title: Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary
Arterial
Hypertension
Lung
Transplantation
MRI
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
First posted: 2015-03-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary arterial hypertension and control patients without increased pulmonary artery pressure who are on the waiting list for double-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 (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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
measure: Ventricular remodeling on cardiac magnetic resonance
timeFrame: Six months postoperative
Secondary outcomes:
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Functional remodeling patterns after LTX, assessed with echocardiography
timeFrame: Six months postoperative
measure: Change in heart failure biomarkers
timeFrame: Six months postoperative
measure: Electrocardiographic remodeling
timeFrame: Six months postoeprative
measure: Electrocardiographic remodeling
timeFrame: Six months postoeprative
measure: Electrocardiographic remodeling
timeFrame: Six months postoeprative
Other outcomes:
measure: Functional outcome
timeFrame: Six months postoperative
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Dirk J van Veldhuisen, MD PhD
role: STUDY_DIRECTOR
References: