Ventricular Reversed Remodeling After LTX in PAH Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Xenon MRI Pulm Hypertension

NCT04991454

Pulmonary Hypertension Pulmonary Arterial Hypertension

RECRUITING PHASE2

Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH

NCT02631421

Pulmonary Arterial Hypertension

COMPLETED

Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging

NCT03078192

Pulmonary Vascular Disease

COMPLETED PHASE2

Right Atrial Fibrosis in Pulmonary Hypertension

NCT04663230

Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension

COMPLETED

Severe CAV MRI in Heart Transplant Recipient

NCT02777255

Cardiac Allograft Vasculopathy

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulmonary arterial hypertension

Patients who are on the waiting list for double-LTX for pulmonary arterial hypertension.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No