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Completed

NCT Number: NCT02391441

Ventricular Reversed Remodeling After LTX in PAH Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute increase in RV ejection fraction

  2. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute increase in LV ejection fraction

  3. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute decrease in RV myocardial mass

  4. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute increase in LV myocardial mass

  5. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute decrease in RV end-diastolic volume

  6. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Absolute increase in LV end-diastolic volume

  7. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Restoration of septal displacement

  8. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Decrease in RV myocardial extracellulair volume assessed with T1-mapping

  9. Ventricular remodeling on cardiac magnetic resonance

    Time frame: Six months postoperative

    Decrease in LV end-systolic eccentricity index

Secondary outcomes

  1. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)

  2. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Increase in myocardial performance index (MPI) or Tei index

  3. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Increase in tricuspid annular systolic motion velocity (i.e. RV s')

  4. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Increase in RV (global/septal/free wall) longitudinal strain

  5. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Decrease in RA size

  6. Functional remodeling patterns after LTX, assessed with echocardiography

    Time frame: Six months postoperative

    Increase in LA size

  7. Change in heart failure biomarkers

    Time frame: Six months postoperative

    Decrease in NT pro-BNP

  8. Electrocardiographic remodeling

    Time frame: Six months postoeprative

    Normalization of RV hypertrophy and strain

  9. Electrocardiographic remodeling

    Time frame: Six months postoeprative

    Normalization of right axis deviation

  10. Electrocardiographic remodeling

    Time frame: Six months postoeprative

    Normalization of right atrial enlargement

Other outcomes

  1. Functional outcome

    Time frame: Six months postoperative

    Decrease in NYHA-class

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Amsterdam UMC, location VUmc

Registry information

Official study title

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

Acronym: PAH-LTX

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2015
Registry last updated
Aug 26, 2019

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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