Ventricular Reversed Remodeling After LTX in PAH Patients

Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02391441

Acronym

PAH-LTX

Enrollment

Registered

2015-03-18

Start date

2015-03-31

Completion date

2019-08-31

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary, Arterial, Hypertension, Lung, Transplantation, MRI

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ventricular remodeling on cardiac magnetic resonance	Six months postoperative	Absolute increase in RV ejection fraction

Secondary

Measure	Time frame	Description
Functional remodeling patterns after LTX, assessed with echocardiography	Six months postoperative	Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)
Change in heart failure biomarkers	Six months postoperative	Decrease in NT pro-BNP
Electrocardiographic remodeling	Six months postoeprative	Normalization of RV hypertrophy and strain

Other

Measure	Time frame	Description
Functional outcome	Six months postoperative	Decrease in NYHA-class

Countries

Netherlands

Outcome results