Ventricular Reversed Remodeling After LTX in PAH Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02391441
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Medical Center Groningen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dirk J van Veldhuisen, MD PhD
Principal Investigator Affiliation	University Medical Center Groningen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Additional Details

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.

Contact a Trial Team

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International Sites

University Medical Center Groningen, Groningen, Netherlands

Status

Address

University Medical Center Groningen

Groningen, , 9713GZ

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