Clinical Trials

Right Atrial Fibrosis in Pulmonary Hypertension

Study Purpose

The study aim to assess right atrial (RA) remodeling, in terms of RA fibrosis, in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension patients. This will be investigated in detail with in-depth cardiac magnet resonance imaging (CMRI). A cohort with exclusion of pulmonary hypertension which underwent CMRI due to dyspnoe of unkown reason will be the control group.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
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
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 or chronic thromboembolic pulmonary hypertension, group 4.

- Invasive exclusion of pulmonary hypertension.

- Age ≥ 18 years.

- Signed informed consent.

- planned right heart catheterization based on clinical grounds.

Exclusion Criteria:

- Other etiologic groups of pulmonary hypertension (WHO group 2, 3, 5) - Patients with congenital heart disease.

- Atrial septal defects.

- Clinical relevant left heart disease.

- Atrial fibrillation / Atrial flutter.

- Ablations of the right atrium.

- History of major cardiac surgery.

- Atrial occlude.

- Metallic implants.

- Pacemakers.

- Severe renal impairment (eGFR < 30 ml/min) - Other severe disease with a life expectancy below 12 month.

- Pregnancy.

- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results.

- Intolerance to a contrast agent containing gadolinium.

- Inability to perform a cardiac magnetic resonance imaging (claustrophobia or similar)

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.	NCT04663230
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 of Giessen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Richter Manuel, MD
Principal Investigator Affiliation	UKGM Giessen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension

Additional Details

Right atrial (RA) function consists of a reservoir, conduit, and active contractile function and can serve as a tool for the evaluation of the severity of RV dysfunction and prognosis in pulmonary hypertension according to recent data. In-depth evaluation of phasic RA function was previously undertaken either by echocardiographic speckle tracking or by cardiac magnetic resonance (CMR) imaging-derived feature tracking. However, it is currently unknown if right atrial remodeling is present. As described for left atrial fibrosis, the presence and extent of atrial fibrosis can be quantified using CMR late gadolinium enhancement. The protocol for the assessment of left atrial fibrosis will be used and adapted to the RA. Patients will undergo 3-dimensional late gadolinium enhancement CMRI along with a contrast-enhanced magnetic resonance angiography and cine imaging in order to define the anatomy of the RA and the superior and inferior vein. High-resolution late gadolinium enhancement images of the RA will be acquired 15 to 30 min after gadolinium-based contrast agents administration using a 3-dimensional inversion-recovery prepared, respiration navigated, and electrocardiogram triggered gradient-echo pulse sequence with fat saturation. Following acquisition of the scans, the endocardial borders of the RA will be defined in each slice by manual tracing. After manual adjustment of the epicardial RA surface, the quantification of fibrosis based on the relative intensity (signal intensity) of late gadolinium enhancement will be performed. Finally, a 3-dimensional model of the RA will be rendered with the maximum enhancement intensities being projected on the model surface.

Arms & Interventions

Arms

: Pulmonary arterial hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg classified into group 1 of the clinical classification of pulmonary hypertension.

: Chronic thromboembolic pulmonary hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with a history of pulmonary embolism, classified into group 4 of the clinical classification of pulmonary hypertension.

: Control

Patients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea.

Interventions

Diagnostic Test: - cardiac magnetic resonance imaging

right atrial late gadolinium enhancement in % and cm2

Contact a Trial Team

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