Ventricular Reversed Remodeling After LTX in PAH Patients (PAH-LTX)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular remodeling on cardiac magnetic resonance	Absolute increase in RV ejection fraction	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV ejection fraction	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Absolute decrease in RV myocardial mass	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV myocardial mass	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Absolute decrease in RV end-diastolic volume	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV end-diastolic volume	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Restoration of septal displacement	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Decrease in RV myocardial extracellulair volume assessed with T1-mapping	Six months postoperative
Ventricular remodeling on cardiac magnetic resonance	Decrease in LV end-systolic eccentricity index	Six months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional remodeling patterns after LTX, assessed with echocardiography	Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)	Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography	Increase in myocardial performance index (MPI) or Tei index	Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography	Increase in tricuspid annular systolic motion velocity (i.e. RV s')	Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography	Increase in RV (global/septal/free wall) longitudinal strain	Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography	Decrease in RA size	Six months postoperative
Functional remodeling patterns after LTX, assessed with echocardiography	Increase in LA size	Six months postoperative
Change in heart failure biomarkers	Decrease in NT pro-BNP	Six months postoperative
Electrocardiographic remodeling	Normalization of RV hypertrophy and strain	Six months postoeprative
Electrocardiographic remodeling	Normalization of right axis deviation	Six months postoeprative
Electrocardiographic remodeling	Normalization of right atrial enlargement	Six months postoeprative

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Amsterdam UMC, location VUmc
• Investigators: Study Director: Dirk J van Veldhuisen, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Hypertension; Lung; Transplantation; Pulmonary; Arterial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: METc2014/134