Right Heart InsufficiencyNCT06663566
Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload
An observational study of Right Heart Insufficiency and Tricuspid Regurgitation, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
\"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Right Heart Insufficiency, Tricuspid Regurgitation
- What is being tested?
- Diagnose the patients right heart function as well as right heart fibrosis and Diagnose the patient's right heart function as well as right heart fibrosis
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Adult, Older adult
Study population: The study was performed in patients with volumetric right ventricular dysfunction. To evaluate the right ventricular function in patients with valvular heart disease and optimize the condition detection and volume therapy in patients with right ventricular dysfunction.
Who may be able to join
- Clinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;
Who cannot join
- Combined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
\"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.
In recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging\'s efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.
The comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration.\"
- Conditions
- Right Heart Insufficiency, Tricuspid Regurgitation
- Being tested
- Diagnose the patients right heart function as well as right heart fibrosis, Diagnose the patient's right heart function as well as right heart fibrosis
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnose the patients right heart function as well as right heart fibrosisOther
Diagnose the patients right heart function as well as right heart fibrosis
Diagnose the patient's right heart function as well as right heart fibrosisDiagnostic test
Diagnose the patient\'s right heart function as well as right heart fibrosis
Diagnose the patient's right heart function as well as right heart fibrosisDiagnostic test
Diagnose the patient\'s right heart function as well as right heart fibrosis
| Study group | Role | What they receive |
|---|---|---|
| high-FAPI+ | FAPI Nuclear Medicine Cardiac Imaging stronge Positive" in English. Receives: Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosis | |
| low-FAPI+ | FAPI Nuclear Medicine Cardiac Imaging Weak Positive" in English. Receives: Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosis | |
| No FAPI+ | FAPI nuclear medicine cardiac imaging negative Receives: Other: Diagnose the patients right heart function as well as right heart fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right heart dysfunction
Central venous pressure（cmH2O）
Measured: 15 days
Right heart dysfunction
P-V Curve of curve（cmH2O）
Measured: 3 mouths
Right heart dysfunction
Duration of tracheal intubation（d)
Measured: 15 days
Right heart dysfunction
P-V Curve of curve
Measured: 15 days
Right heart dysfunction
TAPSE
Measured: 15 days
Right heart dysfunction
TAPSE
Measured: 3 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Right Heart InsufficiencyStudies 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
- 90 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaozheng Zhou, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663566
- Sponsor's protocol ID
- KS2024071
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ye Y, Desai R, Vargas Abello LM, Rajeswaran J, Klein AL, Blackstone EH, Pettersson GB. Effects of right ventricular morphology and function on outcomes of patients with degenerative mitral valve disease. J Thorac Cardiovasc Surg. 2014 Nov;148(5):2012-2020.e8. doi: 10.1016/j.jtcvs.2014.02.082. Epub 2014 Mar 1.
PubMed 24698557Le Tourneau T, Deswarte G, Lamblin N, Foucher-Hossein C, Fayad G, Richardson M, Polge AS, Vannesson C, Topilsky Y, Juthier F, Trochu JN, Enriquez-Sarano M, Bauters C. Right ventricular systolic function in organic mitral regurgitation: impact of biventricular impairment. Circulation. 2013 Apr 16;127(15):1597-608. doi: 10.1161/CIRCULATIONAHA.112.000999. Epub 2013 Mar 13.
PubMed 23487435Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.
PubMed 33559474Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.
PubMed 33722059Kresoja KP, Rommel KP, Lucke C, Unterhuber M, Besler C, von Roeder M, Schober AR, Noack T, Gutberlet M, Thiele H, Lurz P. Right Ventricular Contraction Patterns in Patients Undergoing Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1551-1561. doi: 10.1016/j.jcin.2021.05.005.
PubMed 34294396
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload
- ClinicalTrials.gov ID
- NCT06663566
- Acronym / sponsor ID
- KS2024071
- Conditions
- Right Heart Insufficiency, Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Oct 2024 (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.
\"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.
In recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging\'s efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.
The comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration.\"
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-FAPI+ | – | Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosisFAPI Nuclear Medicine Cardiac Imaging stronge Positive" in English. |
| low-FAPI+ | – | Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosisFAPI Nuclear Medicine Cardiac Imaging Weak Positive" in English. |
| No FAPI+ | – | Other: Diagnose the patients right heart function as well as right heart fibrosisFAPI nuclear medicine cardiac imaging negative |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study was performed in patients with volumetric right ventricular dysfunction. To evaluate the right ventricular function in patients with valvular heart disease and optimize the condition detection and volume therapy in patients with right ventricular dysfunction.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;
Key exclusion criteria (1 listed)
- Combined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;
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 |
|---|---|---|
| Diagnose the patients right heart function as well as right heart fibrosisDiagnose the patients right heart function as well as right heart fibrosis | Other | No FAPI+ |
| Diagnose the patient's right heart function as well as right heart fibrosisDiagnose the patient\'s right heart function as well as right heart fibrosis | Diagnostic test | high-FAPI+ |
| Diagnose the patient's right heart function as well as right heart fibrosisDiagnose the patient\'s right heart function as well as right heart fibrosis | Diagnostic test | low-FAPI+ |
Primary outcome
Right heart dysfunction
Time frame: 15 days
Central venous pressure（cmH2O）
Right heart dysfunction
Time frame: 3 mouths
P-V Curve of curve（cmH2O）
Right heart dysfunction
Time frame: 15 days
Duration of tracheal intubation（d)
Right heart dysfunction
Time frame: 15 days
P-V Curve of curve
Right heart dysfunction
Time frame: 15 days
TAPSE
Right heart dysfunction
Time frame: 3 mouths
TAPSE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 24698557Ye Y, Desai R, Vargas Abello LM, Rajeswaran J, Klein AL, Blackstone EH, Pettersson GB. Effects of right ventricular morphology and function on outcomes of patients with degenerative mitral valve disease. J Thorac Cardiovasc Surg. 2014 Nov;148(5):2012-2020.e8. doi: 10.1016/j.jtcvs.2014.02.082. Epub 2014 Mar 1.
- Results publication: PubMed 23487435Le Tourneau T, Deswarte G, Lamblin N, Foucher-Hossein C, Fayad G, Richardson M, Polge AS, Vannesson C, Topilsky Y, Juthier F, Trochu JN, Enriquez-Sarano M, Bauters C. Right ventricular systolic function in organic mitral regurgitation: impact of biventricular impairment. Circulation. 2013 Apr 16;127(15):1597-608. doi: 10.1161/CIRCULATIONAHA.112.000999. Epub 2013 Mar 13.
- Results publication: PubMed 33559474Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.
- Results publication: PubMed 33722059Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.
- Results publication: PubMed 34294396Kresoja KP, Rommel KP, Lucke C, Unterhuber M, Besler C, von Roeder M, Schober AR, Noack T, Gutberlet M, Thiele H, Lurz P. Right Ventricular Contraction Patterns in Patients Undergoing Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1551-1561. doi: 10.1016/j.jcin.2021.05.005.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Insufficiency and Tricuspid Regurgitation, run by Beijing Anzhen Hospital at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Right heart dysfunction (time frame: 15 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663566, which also lists 5 linked publications.
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 29 Oct 2024.