Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 6, 2015
First Posted Date March 18, 2015
Last Update Posted Date August 26, 2019
Study Start Date March 2015
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2015)
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute increase in RV ejection fraction
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute increase in LV ejection fraction
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute decrease in RV myocardial mass
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute increase in LV myocardial mass
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute decrease in RV end-diastolic volume
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Absolute increase in LV end-diastolic volume
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Restoration of septal displacement
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Decrease in RV myocardial extracellulair volume assessed with T1-mapping
  • Ventricular remodeling on cardiac magnetic resonance [ Time Frame: Six months postoperative ]
    Decrease in LV end-systolic eccentricity index
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02391441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 12, 2015)
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Increase in myocardial performance index (MPI) or Tei index
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Increase in tricuspid annular systolic motion velocity (i.e. RV s')
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Increase in RV (global/septal/free wall) longitudinal strain
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Decrease in RA size
  • Functional remodeling patterns after LTX, assessed with echocardiography [ Time Frame: Six months postoperative ]
    Increase in LA size
  • Change in heart failure biomarkers [ Time Frame: Six months postoperative ]
    Decrease in NT pro-BNP
  • Electrocardiographic remodeling [ Time Frame: Six months postoeprative ]
    Normalization of RV hypertrophy and strain
  • Electrocardiographic remodeling [ Time Frame: Six months postoeprative ]
    Normalization of right axis deviation
  • Electrocardiographic remodeling [ Time Frame: Six months postoeprative ]
    Normalization of right atrial enlargement
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2015)
Functional outcome [ Time Frame: Six months postoperative ]
Decrease in NYHA-class
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood
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
Condition Pulmonary Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 22, 2019)
17
Original Estimated Enrollment
 (submitted: March 12, 2015)
20
Actual Study Completion Date August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02391441
Other Study ID Numbers METc2014/134
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party J.P. van Melle, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators VU University Medical Center
Investigators
Study Director: Dirk J van Veldhuisen, MD PhD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date August 2019