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Integrated Computational modelIng of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217240
Recruitment Status : Unknown
Verified July 2017 by National Heart Centre Singapore.
Recruitment status was:  Recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Ministry of Health, Singapore
Information provided by (Responsible Party):
National Heart Centre Singapore

Brief 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. 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.


Condition or disease Intervention/treatment
Congenital Heart Disease Pulmonary Hypertension Procedure: Cardiac Magnetic Resonance - MRI Other: Cardiopulmonary Exercise Test Other: Blood Sampling for all participants

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Computational modelIing of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease ("INITIATE")
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
Congenital Heart Disease
Tetralogy of Fallot Repair/Pulmonary Hypertension Cardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants
Procedure: Cardiac Magnetic Resonance - MRI
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.

Other: Cardiopulmonary Exercise Test
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.

Other: Blood Sampling for all participants
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

Healthy Volunteer
Cardiac Magnetic Resonance - MRI Cardiopulmonary Exercise Test Blood Sampling for all participants
Procedure: Cardiac Magnetic Resonance - MRI
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.

Other: Cardiopulmonary Exercise Test
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.

Other: Blood Sampling for all participants
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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
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


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.


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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

For patients with repaired tetralogy of Fallot

  1. Survivors of TOF repair more than one year after repair
  2. Aged: 12-80

For patients with pulmonary hypertension

  1. Signed informed consent prior to initiation of any study mandated procedure
  2. Age between 12 - 80 years
  3. 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

  1. Aged :12-80
  2. Asymptomatic and ambulant
  3. Resting blood pressure <140/90 mmHg

Exclusion Criteria:

  1. Non-cardiac illness with a life expectancy of less than 2 years
  2. Previous heart, kidney, liver or lung transplantation
  3. Contraindication to MRI examination

    1. Cardiac pacemaker
    2. Brain aneurysm or clips
    3. Electronic implants or prosthesis
    4. Eye metal foreign body injury
    5. Severe claustrophobia
    6. Severe renal impairment, glomerular filtration rate <30ml/min/1.73m2
  4. Pregnancy

Additional exclusion criteria for healthy volunteers:

  1. 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)
  2. Concurrently taking any medications for cardiovascular disease (including hypertension)
  3. 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)

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): NCT03217240


Contacts
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Contact: Zhong Liang 67042237 ext 2237 zhong.liang@nhcs.com.sg
Contact: Nurkhairunisah Abdul Rahim 67042263 ext 2263 nurkhairunisah.abdul.rahim@nhcs.com.sg

Locations
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Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Contact: Dr Chai Ping    67722165 ext 2165    ping_chai@nuhs.edu.sg   
Sub-Investigator: Dr Chai Ping         
National Heart Centre Recruiting
Singapore, Singapore, 169609
Contact: Nurkhairunisah Binte Abdul Rahim    67042263 ext 2263    nurkhairunisah.abdul.rahim@nhcs.com.sg   
Contact: Yin Siang Liaw    67042274 ext 2274    liaw.yin.siang@nhcs.com.sg   
Principal Investigator: Dr Zhong Liang         
KK Women's and Children's Hospital Not yet recruiting
Singapore, Singapore, 229899
Contact: Dr Tan Teng Hong    63941049 ext 1049    tan.teng.hong@singhealth.com.sg   
Sub-Investigator: Dr Tan Teng Hong         
Sponsors and Collaborators
National Heart Centre Singapore
Ministry of Health, Singapore
Investigators
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Principal Investigator: Dr Zhong Liang Researcher

Additional Information:
Publications:
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers 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.

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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03217240    
Other Study ID Numbers: NHeartCentreS
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities