Congenital Heart DiseaseNCT03217240
Integrated Computational modelIng of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease
An observational study of Congenital Heart Disease and Pulmonary Hypertension, run by National Heart Centre Singapore at 3 sites in Singapore.
Trial summary
Advances in paediatric cardiology and cardiac surgery have enabled the survival of most patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have undergone palliative or reparative surgery earlier in life. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Pulmonary Hypertension
- What is being tested?
- Cardiac Magnetic Resonance - MRI, Cardiopulmonary Exercise Test and Blood Sampling for all participants
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 3 sitesSingapore
- Study dates
- 5 Jun 2017to 30 Aug 2019
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study will recruit 200 patients and 200 Healthy volunteers from across 3 sites at the following institutions: * National Heart Centre * National University Hospital * KK Women's and Children's Hospital 200 Congenital Heart Disease Patients 200 Healthy Volunteer
Who may be able to join
- For patients with repaired tetralogy of Fallot
- Survivors of TOF repair more than one year after repair
- Aged: 12-80
- For patients with pulmonary hypertension
- Signed informed consent prior to initiation of any study mandated procedure
- Age between 12 - 80 years
Show all 11Show fewer
- Patient with clinically suspected or known primary PH belonging to one of the following subgroups of the Updated Dana Point Clinical Classification Group 1 (at least 1 of the following a)Idiopathic (IPAH), or b)Heritable (HPAH), or c)Drug or toxin induced, or d)Associated (APAH) with one of the following: i.Connective tissue disease ii.Congenital heart disease
- For Healthy volunteers
- Aged :12-80
- Asymptomatic and ambulant
- Resting blood pressure <140/90 mmHg
Who cannot join
- Non-cardiac illness with a life expectancy of less than 2 years
- Previous heart, kidney, liver or lung transplantation
- Contraindication to MRI examination
- Cardiac pacemaker
- Brain aneurysm or clips
- Electronic implants or prosthesis
Show all 14Show fewer
- Eye metal foreign body injury
- Severe claustrophobia
- Severe renal impairment, glomerular filtration rate <30ml/min/1.73m2
- Pregnancy
- Additional exclusion criteria for healthy volunteers:
- History of any major medical problems, any cardiovascular disease (such as hypertension or diabetes) or significant renal or lung disease (eg.COPD, Asthma, Pneumonia,Pulmonary embolism,Pulmonary edema,Respiratory tract infection,Bronchiolitis)
- Concurrently taking any medications for cardiovascular disease (including hypertension)
- Heavy smoking (over 5 sticks per day or who has quit smoking in less than 12 months and had smoked over 5 sticks per day)
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Not yet recruiting
National University Hospital
Singapore, 119074
Dr Chai Ping, 67722165 ext. 2165, ping_chai@nuhs.edu.sg
Dr Chai Ping
- Recruiting
National Heart Centre
Singapore, 169609
Nurkhairunisah Binte Abdul Rahim, 67042263 ext. 2263, nurkhairunisah.abdul.rahim@nhcs.com.sg
Yin Siang Liaw, 67042274 ext. 2274, liaw.yin.siang@nhcs.com.sg
- Not yet recruiting
KK Women's and Children's Hospital
Singapore, 229899
Dr Tan Teng Hong, 63941049 ext. 1049, tan.teng.hong@singhealth.com.sg
Dr Tan Teng Hong
About this study
Official title: Integrated Computational modelIing of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease ("INITIATE")
Advances in paediatric cardiology and cardiac surgery have enabled the survival of most patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have undergone palliative or reparative surgery earlier in life. As patients survive into adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is because they are at risk of arrhythmias secondary to structure heart disease and are susceptible to acquired heart disease. In these patients, pre-operative and post-operative evaluation of right ventricular (RV) structure (shape and volume) and function is an essential component of clinical management.
Advances have been made in cardiac imaging so that accurate assessment of the right heart chamber in terms of its structure, function and physiology is possible. However, this technology has as yet never been applied in an effort to comprehensively assess RV structure, function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive assessment of structure and function. Thus, this research will allow development of a comprehensive integrated biomedical engineering (BME) R\&D platform for in-depth study and clinical diagnosis of the RV structure-function relationship and physiology and its association with biomarker, and exercise capacity in CHD.
Read the detailed description
The incidence of Congenital Heart Disease (CHD) in live new-borns is estimated to vary from 4.1/1000 to 12.3/1000. The improvement in survival of CHD patients has led to burgeoning numbers of grown-up CHD.The majority of these CHD patients face a lifetime of problems including RV dilation, ventricular arrhythmias, and sudden cardiac death.Considering inflation to visit costs and added image technology for diagnosis, the cost of each patient is expected to increase .In contrast to adult patients with acquired heart disease, abnormalities of the RV are ubiquitous in children and adults with CHD.
Currently, clinical evaluation includes ECG and pulse oximetry alongside clinical examination. Investigation of RV anatomy and physiology is evolving from a reliance on invasive studies (right heart catheterization or RHC) to non-invasive imaging techniques such as echocardiography, nuclear scintigraphy, computed tomography, and CMR .2D echocardiography is largely operator dependent and suffers from poor inter-study reproducibility.The complex geometry of the RV makes it difficult to accurately quantify remodelling before and after intervention. Nuclear scintigraphy and computed tomography (CT) are constrained by the need for ionizing radiation as well as the poor temporal resolution of the technique.Importantly, existing CMR analytics fail to exploit the full potential of the rich CMR image dataset, and do not yield information on regional RV remodelling, muscle stiffness and blood flow characterization.
Due to the challenges mentioned above, other than RV volumes and ejection fraction, other changes in RV shape and haemodynamics have yet to be considered in the official guidelines used to define eligibility for surgery and to quantify risk of operation. It is plausible that incorporation of additional variables that more comprehensively characterizes fine alterations in RV structure, function and haemodynamics in large risk-stratification models, such as the EuroSCORE and the Society of Thoracic Surgeons' Risk Calculator, may enhance risk stratification and prognostication.
Incorporating novel exploratory RV functional indices (e.g. curvedness, area strain) and computational methods (e.g. CFD, FSI simulations), and then correlating these with clinical and cardiopulmonary exercise test outcomes will allow investigators to have established an unprecedentedly sizeable and rich clinical imaging database that serves both as a touchstone for clinical reference, as well as a repository for future exploratory research.
Investigators tend to develop a comprehensive (BME) Research and Development platform for in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease.
- Conditions
- Congenital Heart Disease, Pulmonary Hypertension
- Being tested
- Cardiac Magnetic Resonance - MRI, Cardiopulmonary Exercise Test, Blood Sampling for all participants
- Medical subject headings
- Heart Defects, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance - MRIProcedure or surgery
All participants will have to undergo CMR which uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images. Participants will be asked to lie on a narrow bed placed inside of a large magnet for about 1 hour. Several sets of images are needed. Participants are required to stay very still and follow the instruction of the MRI technologist who operates the machine from a room next door.
Cardiopulmonary Exercise TestOther
Participants will be asked to undergo a cardiopulmonary exercise test (CPET). Participants will need to wear a mask. Several electrodes will be placed on the chest to record heart activity during exercise. Participants will need to pedal for at least 8-12 minutes. Pedalling will be instructed to report any symptoms such as chest discomfort, shortness of breath, leg fatigue or dizziness. A small probe will be placed on participant's finger during the test to measure the oxygen content in the blood. Immediately after exercising, participants will rest for 5-10 minutes while the blood pressure and electrocardiogram are monitored. The results will be read by a cardiologist.
Blood Sampling for all participantsOther
Serum samples will be obtained before CMR. The sample will be stored at -80 degree until assay. Investigators will perform various tests related to participants heart function
| Study group | Role | What they receive |
|---|---|---|
| Congenital Heart Disease | Tetralogy of Fallot Repair/Pulmonary Hypertension Cardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants Receives: Procedure: Cardiac Magnetic Resonance - MRI; Other: Cardiopulmonary Exercise Test; Other: Blood Sampling for all participants | |
| Healthy Volunteer | Cardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants Receives: Procedure: Cardiac Magnetic Resonance - MRI; Other: Cardiopulmonary Exercise Test; Other: Blood Sampling for all participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a comprehensive (BME) RnD platform for in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease
This research will give an in-depth understanding of RV structure-function relationship, mechanics and haemodynamics. This is the foundation for rationale and physiologically-sound clinical decision-making in CHD monitoring and management. In addition, computational modelling of RV blood flow would be the best tool to optimize an individual solution to RV surgery and may ultimately improve surgical planning. This proposal is a pioneering study that can influence the research field and current management in preoperative, intraoperative, and post-operative interventions in CHD patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start5 Jun 2017
- Primary completionJan 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Sponsor
- Investigators
- Dr Zhong Liang, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217240
- Sponsor's protocol ID
- NHeartCentreS
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Douglas PS, Pontone G, Hlatky MA, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, De Bruyne B; PLATFORM Investigators. Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study. Eur Heart J. 2015 Dec 14;36(47):3359-67. doi: 10.1093/eurheartj/ehv444. Epub 2015 Sep 1.
PubMed 26330417Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
PubMed 22922562Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
PubMed 22032711Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
PubMed 22922698Egidy Assenza G, Cassater D, Landzberg M, Geva T, Schreier J, Graham D, Volpe M, Barker N, Economy K, Valente AM. The effects of pregnancy on right ventricular remodeling in women with repaired tetralogy of Fallot. Int J Cardiol. 2013 Oct 3;168(3):1847-52. doi: 10.1016/j.ijcard.2012.12.071. Epub 2013 Jan 28.
PubMed 23369674Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol. 2004 Mar 17;43(6):1068-74. doi: 10.1016/j.jacc.2003.10.045.
PubMed 15028368Warnes CA. Adult congenital heart disease importance of the right ventricle. J Am Coll Cardiol. 2009 Nov 17;54(21):1903-10. doi: 10.1016/j.jacc.2009.06.048.
PubMed 19909869Kilner PJ, Geva T, Kaemmerer H, Trindade PT, Schwitter J, Webb GD. Recommendations for cardiovascular magnetic resonance in adults with congenital heart disease from the respective working groups of the European Society of Cardiology. Eur Heart J. 2010 Apr;31(7):794-805. doi: 10.1093/eurheartj/ehp586. Epub 2010 Jan 11.
PubMed 20067914Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031Hu M, Zhao X, Tan RS, Lee PT, Yang P, Leng S, Song Y, Zhang X, van der Geest RJ, Garg P, Gong L, Zhong L. Prognostic Value of Left Ventricular Kinetic Energy for Predicting Major Adverse Events in Hypertrophic Cardiomyopathy. JACC Asia. 2026 Apr;6(4):493-506. doi: 10.1016/j.jacasi.2025.10.013.
PubMed 41949241Zhao X, Lee PT, Hu L, Tan RS, Chai P, Yeo TJ, Leng S, Ouyang R, Bryant JA, Teo LLS, van der Geest RJ, Yip JW, Tan JL, Zhong Y, Zhong L. Right Ventricular Restrictive Physiology Is Associated With Right Ventricular Direct Flow From 4D Flow CMR. JACC Asia. 2024 Oct 22;4(12):912-924. doi: 10.1016/j.jacasi.2024.08.019. eCollection 2024 Dec.
PubMed 39802994Zhao X, Tan RS, Garg P, Chai P, Leng S, Bryant JA, Teo LLS, Yeo TJ, Fortier MV, Low TT, Ong CC, Zhang S, Van der Geest RJ, Allen JC, Tan TH, Yip JW, Tan JL, Hughes M, Plein S, Westenberg JJM, Zhong L. Age- and sex-specific reference values of biventricular flow components and kinetic energy by 4D flow cardiovascular magnetic resonance in healthy subjects. J Cardiovasc Magn Reson. 2023 Sep 18;25(1):50. doi: 10.1186/s12968-023-00960-x.
PubMed 37718441Zhao X, Garg P, Assadi H, Tan RS, Chai P, Yeo TJ, Matthews G, Mehmood Z, Leng S, Bryant JA, Teo LLS, Ong CC, Yip JW, Tan JL, van der Geest RJ, Zhong L. Aortic flow is associated with aging and exercise capacity. Eur Heart J Open. 2023 Aug 26;3(4):oead079. doi: 10.1093/ehjopen/oead079. eCollection 2023 Jul.
PubMed 37635784Zhao X, Leng S, Tan RS, Chai P, Yeo TJ, Bryant JA, Teo LLS, Fortier MV, Ruan W, Low TT, Ong CC, Zhang S, van der Geest RJ, Allen JC, Hughes M, Garg P, Tan TH, Yip JW, Tan JL, Zhong L. Right ventricular energetic biomarkers from 4D Flow CMR are associated with exertional capacity in pulmonary arterial hypertension. J Cardiovasc Magn Reson. 2022 Dec 1;24(1):61. doi: 10.1186/s12968-022-00896-8.
PubMed 36451198Zhao X, Hu L, Leng S, Tan RS, Chai P, Bryant JA, Teo LLS, Fortier MV, Yeo TJ, Ouyang RZ, Allen JC, Hughes M, Garg P, Zhang S, van der Geest RJ, Yip JW, Tan TH, Tan JL, Zhong Y, Zhong L. Ventricular flow analysis and its association with exertional capacity in repaired tetralogy of Fallot: 4D flow cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2022 Jan 3;24(1):4. doi: 10.1186/s12968-021-00832-2.
PubMed 34980199
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Computational modelIing of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease ("INITIATE")
- ClinicalTrials.gov ID
- NCT03217240
- Acronym / sponsor ID
- NHeartCentreS
- Conditions
- Congenital Heart Disease, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 14 Jul 2017 (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.
Advances in paediatric cardiology and cardiac surgery have enabled the survival of most patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have undergone palliative or reparative surgery earlier in life. As patients survive into adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is because they are at risk of arrhythmias secondary to structure heart disease and are susceptible to acquired heart disease. In these patients, pre-operative and post-operative evaluation of right ventricular (RV) structure (shape and volume) and function is an essential component of clinical management.
Advances have been made in cardiac imaging so that accurate assessment of the right heart chamber in terms of its structure, function and physiology is possible. However, this technology has as yet never been applied in an effort to comprehensively assess RV structure, function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive assessment of structure and function. Thus, this research will allow development of a comprehensive integrated biomedical engineering (BME) R\&D platform for in-depth study and clinical diagnosis of the RV structure-function relationship and physiology and its association with biomarker, and exercise capacity in CHD.
Detailed description
The incidence of Congenital Heart Disease (CHD) in live new-borns is estimated to vary from 4.1/1000 to 12.3/1000. The improvement in survival of CHD patients has led to burgeoning numbers of grown-up CHD.The majority of these CHD patients face a lifetime of problems including RV dilation, ventricular arrhythmias, and sudden cardiac death.Considering inflation to visit costs and added image technology for diagnosis, the cost of each patient is expected to increase .In contrast to adult patients with acquired heart disease, abnormalities of the RV are ubiquitous in children and adults with CHD.
Currently, clinical evaluation includes ECG and pulse oximetry alongside clinical examination. Investigation of RV anatomy and physiology is evolving from a reliance on invasive studies (right heart catheterization or RHC) to non-invasive imaging techniques such as echocardiography, nuclear scintigraphy, computed tomography, and CMR .2D echocardiography is largely operator dependent and suffers from poor inter-study reproducibility.The complex geometry of the RV makes it difficult to accurately quantify remodelling before and after intervention. Nuclear scintigraphy and computed tomography (CT) are constrained by the need for ionizing radiation as well as the poor temporal resolution of the technique.Importantly, existing CMR analytics fail to exploit the full potential of the rich CMR image dataset, and do not yield information on regional RV remodelling, muscle stiffness and blood flow characterization.
Due to the challenges mentioned above, other than RV volumes and ejection fraction, other changes in RV shape and haemodynamics have yet to be considered in the official guidelines used to define eligibility for surgery and to quantify risk of operation. It is plausible that incorporation of additional variables that more comprehensively characterizes fine alterations in RV structure, function and haemodynamics in large risk-stratification models, such as the EuroSCORE and the Society of Thoracic Surgeons' Risk Calculator, may enhance risk stratification and prognostication.
Incorporating novel exploratory RV functional indices (e.g. curvedness, area strain) and computational methods (e.g. CFD, FSI simulations), and then correlating these with clinical and cardiopulmonary exercise test outcomes will allow investigators to have established an unprecedentedly sizeable and rich clinical imaging database that serves both as a touchstone for clinical reference, as well as a repository for future exploratory research.
Investigators tend to develop a comprehensive (BME) Research and Development platform for in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital Heart Disease | – | Procedure: Cardiac Magnetic Resonance - MRI, Other: Cardiopulmonary Exercise Test, Other: Blood Sampling for all participantsTetralogy of Fallot Repair/Pulmonary Hypertension Cardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants |
| Healthy Volunteer | – | Procedure: Cardiac Magnetic Resonance - MRI, Other: Cardiopulmonary Exercise Test, Other: Blood Sampling for all participantsCardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study will recruit 200 patients and 200 Healthy volunteers from across 3 sites at the following institutions: * National Heart Centre * National University Hospital * KK Women's and Children's Hospital 200 Congenital Heart Disease Patients 200 Healthy Volunteer
Key inclusion criteria (11 listed)
- For patients with repaired tetralogy of Fallot
- Survivors of TOF repair more than one year after repair
- Aged: 12-80
- For patients with pulmonary hypertension
- Signed informed consent prior to initiation of any study mandated procedure
Key exclusion criteria (14 listed)
- Non-cardiac illness with a life expectancy of less than 2 years
- Previous heart, kidney, liver or lung transplantation
- Contraindication to MRI examination
- Pregnancy
- History of any major medical problems, any cardiovascular disease (such as hypertension or diabetes) or significant renal or lung disease (eg.COPD, Asthma, Pneumonia,Pulmonary embolism,Pulmonary edema,Respiratory tract infection,Bronchiolitis)
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 - MRIAll participants will have to undergo CMR which uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images. Participants will be asked to lie on a narrow bed placed inside of a large magnet for about 1 hour. Several sets of images are needed. Participants are required to stay very still and follow the instruction of the MRI technologist who operates the machine from a room next door. | Procedure or surgery | Congenital Heart Disease, Healthy Volunteer |
| Cardiopulmonary Exercise TestParticipants will be asked to undergo a cardiopulmonary exercise test (CPET). Participants will need to wear a mask. Several electrodes will be placed on the chest to record heart activity during exercise. Participants will need to pedal for at least 8-12 minutes. Pedalling will be instructed to report any symptoms such as chest discomfort, shortness of breath, leg fatigue or dizziness. A small probe will be placed on participant's finger during the test to measure the oxygen content in the blood. Immediately after exercising, participants will rest for 5-10 minutes while the blood pressure and electrocardiogram are monitored. The results will be read by a cardiologist. | Other | Congenital Heart Disease, Healthy Volunteer |
| Blood Sampling for all participantsSerum samples will be obtained before CMR. The sample will be stored at -80 degree until assay. Investigators will perform various tests related to participants heart function | Other | Congenital Heart Disease, Healthy Volunteer |
Primary outcome
Develop a comprehensive (BME) RnD platform for in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease
Time frame: 3 years
This research will give an in-depth understanding of RV structure-function relationship, mechanics and haemodynamics. This is the foundation for rationale and physiologically-sound clinical decision-making in CHD monitoring and management. In addition, computational modelling of RV blood flow would be the best tool to optimize an individual solution to RV surgery and may ultimately improve surgical planning. This proposal is a pioneering study that can influence the research field and current management in preoperative, intraoperative, and post-operative interventions in CHD patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Background: PubMed 26330417Douglas PS, Pontone G, Hlatky MA, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, De Bruyne B; PLATFORM Investigators. Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study. Eur Heart J. 2015 Dec 14;36(47):3359-67. doi: 10.1093/eurheartj/ehv444. Epub 2015 Sep 1.
- Background: PubMed 22922562Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
- Background: PubMed 22032711Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
- Background: PubMed 22922698Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
- Background: PubMed 23369674Egidy Assenza G, Cassater D, Landzberg M, Geva T, Schreier J, Graham D, Volpe M, Barker N, Economy K, Valente AM. The effects of pregnancy on right ventricular remodeling in women with repaired tetralogy of Fallot. Int J Cardiol. 2013 Oct 3;168(3):1847-52. doi: 10.1016/j.ijcard.2012.12.071. Epub 2013 Jan 28.
- Background: PubMed 15028368Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol. 2004 Mar 17;43(6):1068-74. doi: 10.1016/j.jacc.2003.10.045.
- Background: PubMed 19909869Warnes CA. Adult congenital heart disease importance of the right ventricle. J Am Coll Cardiol. 2009 Nov 17;54(21):1903-10. doi: 10.1016/j.jacc.2009.06.048.
- Background: PubMed 20067914Kilner PJ, Geva T, Kaemmerer H, Trindade PT, Schwitter J, Webb GD. Recommendations for cardiovascular magnetic resonance in adults with congenital heart disease from the respective working groups of the European Society of Cardiology. Eur Heart J. 2010 Apr;31(7):794-805. doi: 10.1093/eurheartj/ehp586. Epub 2010 Jan 11.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Derived from this study: PubMed 41949241Hu M, Zhao X, Tan RS, Lee PT, Yang P, Leng S, Song Y, Zhang X, van der Geest RJ, Garg P, Gong L, Zhong L. Prognostic Value of Left Ventricular Kinetic Energy for Predicting Major Adverse Events in Hypertrophic Cardiomyopathy. JACC Asia. 2026 Apr;6(4):493-506. doi: 10.1016/j.jacasi.2025.10.013.
- Derived from this study: PubMed 39802994Zhao X, Lee PT, Hu L, Tan RS, Chai P, Yeo TJ, Leng S, Ouyang R, Bryant JA, Teo LLS, van der Geest RJ, Yip JW, Tan JL, Zhong Y, Zhong L. Right Ventricular Restrictive Physiology Is Associated With Right Ventricular Direct Flow From 4D Flow CMR. JACC Asia. 2024 Oct 22;4(12):912-924. doi: 10.1016/j.jacasi.2024.08.019. eCollection 2024 Dec.
- Derived from this study: PubMed 37718441Zhao X, Tan RS, Garg P, Chai P, Leng S, Bryant JA, Teo LLS, Yeo TJ, Fortier MV, Low TT, Ong CC, Zhang S, Van der Geest RJ, Allen JC, Tan TH, Yip JW, Tan JL, Hughes M, Plein S, Westenberg JJM, Zhong L. Age- and sex-specific reference values of biventricular flow components and kinetic energy by 4D flow cardiovascular magnetic resonance in healthy subjects. J Cardiovasc Magn Reson. 2023 Sep 18;25(1):50. doi: 10.1186/s12968-023-00960-x.
- Clinical outcomes of fractional flow reserve.Link provided by the sponsor.
- Diagnostic accuracy of fractional flow reserve from anatomic CT angiographyLink provided by the sponsor.
- Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms.Link provided by the sponsor.
- Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS).Link provided by the sponsor.
- The effects of pregnancy on right ventricular remodeling in women with repaired tetralogy of FallotLink provided by the sponsor.
- Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imagingLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Dr Zhong Liang principal investigator
Researcher
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pulmonary Hypertension, run by National Heart Centre Singapore at 3 sites in Singapore.
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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Liang (67042237 ext. 2237, zhong.liang@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a comprehensive (BME) RnD platform for in-depth study of RV mechanics, blood flow and function in Congenital Heart Disease (time frame: 3 years). 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 NCT03217240, which also lists 16 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 14 Jul 2017.