Right Atrial Fibrosis in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— RAFE-PH  

Official title:

Right Atrial Fibrosis in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663230
• Other study ID #: AZ 12320
• Status: Completed
• Start date: April 30, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2024
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik	Bad Nauheim	Hesse
Germany	University of Giessen	Gießen	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrosis	right atrial late gadolinium enhancement in % and cm2	1 day
Secondary	Correlation of right atrial fibrosis with functional and exercise capacity	right atrial late gadolinium enhancement in % and cm2 correlated with 6minute walking distance in m or peak oxygen uptake in ml/min/kg	1 day
Secondary	Correlation of right atrial fibrosis with remodeling of the right atrium, backflow and systemic congestion	right atrial late gadolinium enhancement in % and cm2 correlated with right atrial size (volume and cm2) and inferior vena cava diameter in cm2	1 day
Secondary	Correlation of right atrial fibrosis with pulmonary hemodynamics	right atrial late gadolinium enhancement in % and cm2 correlated with mean right atrial pressure	1 day
Secondary	Correlation of right atrial fibrosis with load-independent right ventricular function assessed by pressure-volume loop catheterization	right atrial late gadolinium enhancement in % and cm2 correlated with end-systolic to arterial elastance	1 day
Secondary	Correlation of right atrial fibrosis with biomarkers	right atrial late gadolinium enhancement in % and cm2 correlated with B-type natriuretic peptide in pg/ml	1 day
Secondary	Prognostic relevance of right atrial fibrosis	right atrial late gadolinium enhancement in % and cm2 as a predictor of clinical worsening or death	1 day