Ventricular Reversed Remodeling After LTX in PAH Patients

Pulmonary Arterial Hypertension Clinical Trial

— PAH-LTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391441
• Other study ID #: METc2014/134
• Status: Completed
• Start date: March 2015
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional outcome	Decrease in NYHA-class	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute increase in RV ejection fraction	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV ejection fraction	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute decrease in RV myocardial mass	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV myocardial mass	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute decrease in RV end-diastolic volume	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Absolute increase in LV end-diastolic volume	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Restoration of septal displacement	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Decrease in RV myocardial extracellulair volume assessed with T1-mapping	Six months postoperative
Primary	Ventricular remodeling on cardiac magnetic resonance	Decrease in LV end-systolic eccentricity index	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Increase in tricuspid annular plane systolic excursion (i.e. TAPSE)	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Increase in myocardial performance index (MPI) or Tei index	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Increase in tricuspid annular systolic motion velocity (i.e. RV s')	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Increase in RV (global/septal/free wall) longitudinal strain	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Decrease in RA size	Six months postoperative
Secondary	Functional remodeling patterns after LTX, assessed with echocardiography	Increase in LA size	Six months postoperative
Secondary	Change in heart failure biomarkers	Decrease in NT pro-BNP	Six months postoperative
Secondary	Electrocardiographic remodeling	Normalization of RV hypertrophy and strain	Six months postoeprative
Secondary	Electrocardiographic remodeling	Normalization of right axis deviation	Six months postoeprative
Secondary	Electrocardiographic remodeling	Normalization of right atrial enlargement	Six months postoeprative