Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Right Atrial Fibrosis in Pulmonary Hypertension (RAFE-PH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663230
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Giessen

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension Diagnostic Test: cardiac magnetic resonance imaging

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Right Atrial Fibrosis in Pulmonary Hypertension
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 Diagnostic Test: cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
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.
 Diagnostic Test: cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
Control
Patients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea.
 Diagnostic Test: cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. atrial fibrosis [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2


Secondary Outcome Measures :
  1. Correlation of right atrial fibrosis with functional and exercise capacity [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 correlated with 6minute walking distance in m or peak oxygen uptake in ml/min/kg

  2. Correlation of right atrial fibrosis with remodeling of the right atrium, backflow and systemic congestion [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 correlated with right atrial size (volume and cm2) and inferior vena cava diameter in cm2

  3. Correlation of right atrial fibrosis with pulmonary hemodynamics [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 correlated with mean right atrial pressure

  4. Correlation of right atrial fibrosis with load-independent right ventricular function assessed by pressure-volume loop catheterization [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 correlated with end-systolic to arterial elastance

  5. Correlation of right atrial fibrosis with biomarkers [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 correlated with B-type natriuretic peptide in pg/ml

  6. Prognostic relevance of right atrial fibrosis [ Time Frame: 1 day ]
    right atrial late gadolinium enhancement in % and cm2 as a predictor of clinical worsening or death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
40 subjects with pulmonary arterial hypertension, group 1 and chronic thromboembolic pulmonary hypertension, group 4; Patients with invasive exclusion of pulmonary hypertension undergoing diagnostic right heart catheterisation due to dyspnoe will serve as control
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663230


Contacts
Layout table for location contacts
Contact: Richter Manuel, MD +4964198556022 manuel.j.richter@innere.med.uni-giessen.de

Locations
Layout table for location information
Germany
Kerckhoff-Klinik Recruiting
Bad Nauheim, Hesse, Germany
Contact: Richter Manuel, MD    +4964198556022    manuel.j.richter@innere.med.uni-giessen.de   
University of Giessen Recruiting
Gießen, Hesse, Germany, 35390
Contact: Manuel Richter, MD    +4964198556022    manuel.j.richter@innere.med.uni-giessen.de   
Sub-Investigator: Khodr Tello, MD         
Sponsors and Collaborators
University of Giessen
Investigators
Layout table for investigator information
Principal Investigator: Richter Manuel, MD UKGM Giessen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04663230    
Other Study ID Numbers: AZ 12320
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon reasonable request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases