Ventricular Reversed Remodeling After LTX in PAH Patients

Completed

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT02391441
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular remodeling on cardiac magnetic resonance	Six months postoperative	Decrease in LV end-systolic eccentricity index

Secondary Outcome Measures

Name	Time	Method
Change in heart failure biomarkers	Six months postoperative	Decrease in NT pro-BNP
Functional remodeling patterns after LTX, assessed with echocardiography	Six months postoperative	Increase in LA size
Electrocardiographic remodeling	Six months postoeprative	Normalization of right atrial enlargement

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands