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

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ClinicalTrials.gov Identifier: NCT02391441
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
VU University Medical Center
Information provided by (Responsible Party):
J.P. van Melle, University Medical Center Groningen

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 17 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Imaging of Ventricular Reversed Remodeling After Double Lung Transplantation in Patients With Pulmonary Arterial Hypertension
Study Start Date : March 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Functional outcome [ Time Frame: Six months postoperative ]
    Decrease in NYHA-class


Biospecimen Retention:   Samples Without DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391441


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Center Groningen
VU University Medical Center
Investigators
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Study Director: Dirk J van Veldhuisen, MD PhD University Medical Center Groningen

Additional Information:

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Responsible Party: J.P. van Melle, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02391441     History of Changes
Other Study ID Numbers: METc2014/134
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by J.P. van Melle, University Medical Center Groningen:
Pulmonary
Arterial
Hypertension
Lung
Transplantation
MRI
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases