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Clinical Trials/NCT02391441
NCT02391441
Completed
Not Applicable

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

University Medical Center Groningen1 site in 1 country17 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
University Medical Center Groningen
Enrollment
17
Locations
1
Primary Endpoint
Ventricular remodeling on cardiac magnetic resonance
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
August 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

J.P. van Melle

MD PhD

University Medical Center Groningen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ventricular remodeling on cardiac magnetic resonance

Time Frame: Six months postoperative

Decrease in LV end-systolic eccentricity index

Secondary Outcomes

  • Change in heart failure biomarkers(Six months postoperative)
  • Functional remodeling patterns after LTX, assessed with echocardiography(Six months postoperative)
  • Electrocardiographic remodeling(Six months postoeprative)

Study Sites (1)

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