Pulmonary HypertensionRAFE-PHNCT04663230
Right Atrial Fibrosis in Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of Giessen at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- What is being tested?
- cardiac magnetic resonance imaging
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Apr 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff-Klinik
Bad Nauheim, Hesse
University of Giessen
Giessen, Hesse, 35390
About this study
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.
Read the 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.
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- Being tested
- cardiac magnetic resonance imaging
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance imagingDiagnostic test
right atrial late gadolinium enhancement in % and cm2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: cardiac magnetic resonance imaging | |
| 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. Receives: Diagnostic Test: cardiac magnetic resonance imaging | |
| Control | Patients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea. Receives: Diagnostic Test: cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrosis
right atrial late gadolinium enhancement in % and cm2
Measured: 1 day
Secondary outcomes (6)
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
Measured: 1 day
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
Measured: 1 day
Correlation of right atrial fibrosis with pulmonary hemodynamics
right atrial late gadolinium enhancement in % and cm2 correlated with mean right atrial pressure
Measured: 1 day
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
Measured: 1 day
Correlation of right atrial fibrosis with biomarkers
right atrial late gadolinium enhancement in % and cm2 correlated with B-type natriuretic peptide in pg/ml
Measured: 1 day
Prognostic relevance of right atrial fibrosis
right atrial late gadolinium enhancement in % and cm2 as a predictor of clinical worsening or death
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start30 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richter Manuel, MD, Principal investigator, UKGM Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663230
- Sponsor's protocol ID
- AZ 12320
- Acronym
- RAFE-PH
- Status last verified
- May 2024
- First submitted
- 9 Nov 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Atrial Fibrosis in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04663230
- Acronym / sponsor ID
- RAFE-PH / AZ 12320
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | Diagnostic Test: cardiac magnetic resonance imagingPatients 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 | – | Diagnostic Test: cardiac magnetic resonance imagingPatients 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 | – | Diagnostic Test: cardiac magnetic resonance imagingPatients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac magnetic resonance imagingright atrial late gadolinium enhancement in % and cm2 | Diagnostic test | Chronic thromboembolic pulmonary hypertension, Control, Pulmonary arterial hypertension |
Primary outcome
atrial fibrosis
Time frame: 1 day
right atrial late gadolinium enhancement in % and cm2
6 secondary outcomes
Correlation of right atrial fibrosis with functional and exercise capacity
Time frame: 1 day
Correlation of right atrial fibrosis with remodeling of the right atrium, backflow and systemic congestion
Time frame: 1 day
Correlation of right atrial fibrosis with pulmonary hemodynamics
Time frame: 1 day
Correlation of right atrial fibrosis with load-independent right ventricular function assessed by pressure-volume loop catheterization
Time frame: 1 day
Correlation of right atrial fibrosis with biomarkers
Time frame: 1 day
Prognostic relevance of right atrial fibrosis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richter Manuel, MD principal investigator
UKGM Giessen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of Giessen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrosis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.