Hypertrophic CardiomyopathyNCT06381778
Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis
An observational study of Hypertrophic Cardiomyopathy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 2,600 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Feb 2023to 1 Dec 2027
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Presence of left ventricular hypertrophy
Who may be able to join
- Presence of left ventricular hypertrophy (LVH) on echo/CMRI:
- maximal interventricular septal (IVST) and/or posterior wall thickness (PWT) ≥13 mm,
- apical wall thickness ≥15 mm or a ratio of apical to basal LV wall thickness of ≥ 1.3 at end-diastole, OR
- maximal LV wall thickness ≥ 15mm of ANY OTHER PART
- Male and female adult age ≥ 20 year-old
- Patients willing to comply with and sign the informed consent
Who cannot join
- Patients refuse or unable to give informed consent
- Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the program
- Co-arctation of the aorta, severe aortic stenosis, or severe LV pressure overload
- Athletic heart
- Non-compaction cardiomyopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Yen-Wen Wu, MD, PhD, 886-2-8966-7000 ext. 1090, wuyw0502@gmail.com
Yen-Wen Wu, MD, PhD
About this study
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan.
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) . Studies across geographic areas report a prevalence of unexplained LVH at 0.02-0.23% in adults, and a trend of age-related prevalence, with lower rates in patients under the age of 25 years . HCM may present in a wide variety of patterns. Its natural history includes the development of progressive, life-limiting symptoms due to left ventricular outflow tract (LVOT) obstruction or diastolic dysfunction, atrial arrhythmias, heart failure (HF) associated with systolic dysfunction and risk of ventricular arrhythmias. HCM is frequently transmitted in an autosomal dominant manner. Known etiologies include mutations in the genes related to sarcomeric proteins, metabolic disorders, neuromuscular diseases, and inflammation. The good prognosis depends on early diagnosis and correct treatment strategy.
Fabry disease (FD) is an X-linked rare disease caused by mutations in the GLA gene, which encodes alpha-galactosidase A (alpha-GAL A). Defects in alpha-GAL A leads to accumulation of Gb3 in cells, which in turn impairs the function tissues and organs. Different GLA variants may be related to various symptoms in different organs, and these variants can be categorized into two types: classic and late-onset. In classic type of patients, the disease manifestations usually occur in childhood with common symptoms such as extremity pain, nausea, fever of unknown origin and hypohidrosis. In addition, classic FD patient may present renal and cardiac deteriorations as well as cerebrovascular manifestations. These manifestations may further develop into life-threatening complications at middle or late age if untreated [4]. On the other hand, disease onset in late-onset type of FD patients is typically in adulthood, and the clinical manifestations may be limited to fewer organs compared to what was found in the classic type. For example, cardiac variants IVS4+919G>A and p.N215S tend to affect the heart. Because cardiac abnormalities in FD such as LVH is like what is observed in several heart conditions such as HCM and cardiac amyloidosis, differential diagnosis between FD and other heart conditions is a topic of great research and clinical interest.
Although LVH is a common feature between FD and HCM, the prevalence of FD in HCM patients is usually limited to 1-2%. Hence, several recent reports strive to describe the development of criteria to increase the accuracy of diagnosis of FD in HCM/LVH populations. Seo et al. prospectively assessed the cardiac screening criteria to increase the chance of identification of FD in HCM patients via integration of data on short PR interval, arrhythmia, and symptoms of autonomic function. In addition, Fan et al. focused on patients with IVST or PWT ≥ 13 mm on echocardiography, and excluded patients with known sarcomeric gene mutations, amyloidosis, athletic heart, non-compaction cardiomyopathy, and non-FD metabolic or syndromic conditions associated with LVH. However, these reports are limited to single or very few centers. Moreover, it needs to be cautious to interpret these study results due to various distribution of FD mutations in different countries or geographic areas.
On the other hand, amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. The most common mutation in Taiwan is A97S, 80% have LVH. And bone-avid tracers such as 99mTc-PYP/DPD/HMDP could detect CA, which may be related to the microcalcification. Recent advances in therapeutic strategies shown to be most beneficial in the early stages of the disease have determined a paradigm shift in the screening, diagnostic algorithm, and risk classification of patients with ATTR-CM.
Patients with HCM have genotypic and phenotypic variability. There are a number of treatment modalities for these patients, including pharmacotherapy to control symptoms, implantable cardiac defibrillators to manage malignant arrhythmias, and surgical myectomy and septal ablation to decrease the left ventricular outflow obstruction. Accurate diagnosis is vital for the perioperative management of these patients. Of note, other LVH conditions such as FD, CA also have specific genetic background in Taiwan. In this program, Taiwan Socieyt of Cardiology aims to establish a multi-center registry that includes FD and selected heart conditions featured by unexplained LVH. This registry will allow understanding of the clinical features and disease patterns of patients with unexplained LVH in Taiwan. With systematic documentation of features of FD and non-FD patients across Taiwan, this registry might serve as an asset for future research such as development of scoring algorithm to identify FD more precisely, and generate the specific "reg-flag" signs in FD, in comparison with HCM or CA in Taiwan. Moreover, with documentation of clinical and biochemical parameters and clinical follow-up, this registry will allow future research to understand the natural history of FD or HCM, and long-term treatment outcomes of these diseases in Taiwan.
- Conditions
- Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death
Measured: 1 year
Secondary outcomes (1)
CV death
CV death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start6 Feb 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Wen Wu, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381778
- Sponsor's protocol ID
- 112006-E
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis
- ClinicalTrials.gov ID
- NCT06381778
- Acronym / sponsor ID
- 112006-E
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Apr 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.
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan.
Detailed description
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) . Studies across geographic areas report a prevalence of unexplained LVH at 0.02-0.23% in adults, and a trend of age-related prevalence, with lower rates in patients under the age of 25 years . HCM may present in a wide variety of patterns. Its natural history includes the development of progressive, life-limiting symptoms due to left ventricular outflow tract (LVOT) obstruction or diastolic dysfunction, atrial arrhythmias, heart failure (HF) associated with systolic dysfunction and risk of ventricular arrhythmias. HCM is frequently transmitted in an autosomal dominant manner. Known etiologies include mutations in the genes related to sarcomeric proteins, metabolic disorders, neuromuscular diseases, and inflammation. The good prognosis depends on early diagnosis and correct treatment strategy.
Fabry disease (FD) is an X-linked rare disease caused by mutations in the GLA gene, which encodes alpha-galactosidase A (alpha-GAL A). Defects in alpha-GAL A leads to accumulation of Gb3 in cells, which in turn impairs the function tissues and organs. Different GLA variants may be related to various symptoms in different organs, and these variants can be categorized into two types: classic and late-onset. In classic type of patients, the disease manifestations usually occur in childhood with common symptoms such as extremity pain, nausea, fever of unknown origin and hypohidrosis. In addition, classic FD patient may present renal and cardiac deteriorations as well as cerebrovascular manifestations. These manifestations may further develop into life-threatening complications at middle or late age if untreated [4]. On the other hand, disease onset in late-onset type of FD patients is typically in adulthood, and the clinical manifestations may be limited to fewer organs compared to what was found in the classic type. For example, cardiac variants IVS4+919G>A and p.N215S tend to affect the heart. Because cardiac abnormalities in FD such as LVH is like what is observed in several heart conditions such as HCM and cardiac amyloidosis, differential diagnosis between FD and other heart conditions is a topic of great research and clinical interest.
Although LVH is a common feature between FD and HCM, the prevalence of FD in HCM patients is usually limited to 1-2%. Hence, several recent reports strive to describe the development of criteria to increase the accuracy of diagnosis of FD in HCM/LVH populations. Seo et al. prospectively assessed the cardiac screening criteria to increase the chance of identification of FD in HCM patients via integration of data on short PR interval, arrhythmia, and symptoms of autonomic function. In addition, Fan et al. focused on patients with IVST or PWT ≥ 13 mm on echocardiography, and excluded patients with known sarcomeric gene mutations, amyloidosis, athletic heart, non-compaction cardiomyopathy, and non-FD metabolic or syndromic conditions associated with LVH. However, these reports are limited to single or very few centers. Moreover, it needs to be cautious to interpret these study results due to various distribution of FD mutations in different countries or geographic areas.
On the other hand, amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. The most common mutation in Taiwan is A97S, 80% have LVH. And bone-avid tracers such as 99mTc-PYP/DPD/HMDP could detect CA, which may be related to the microcalcification. Recent advances in therapeutic strategies shown to be most beneficial in the early stages of the disease have determined a paradigm shift in the screening, diagnostic algorithm, and risk classification of patients with ATTR-CM.
Patients with HCM have genotypic and phenotypic variability. There are a number of treatment modalities for these patients, including pharmacotherapy to control symptoms, implantable cardiac defibrillators to manage malignant arrhythmias, and surgical myectomy and septal ablation to decrease the left ventricular outflow obstruction. Accurate diagnosis is vital for the perioperative management of these patients. Of note, other LVH conditions such as FD, CA also have specific genetic background in Taiwan. In this program, Taiwan Socieyt of Cardiology aims to establish a multi-center registry that includes FD and selected heart conditions featured by unexplained LVH. This registry will allow understanding of the clinical features and disease patterns of patients with unexplained LVH in Taiwan. With systematic documentation of features of FD and non-FD patients across Taiwan, this registry might serve as an asset for future research such as development of scoring algorithm to identify FD more precisely, and generate the specific "reg-flag" signs in FD, in comparison with HCM or CA in Taiwan. Moreover, with documentation of clinical and biochemical parameters and clinical follow-up, this registry will allow future research to understand the natural history of FD or HCM, and long-term treatment outcomes of these diseases in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Presence of left ventricular hypertrophy
Key inclusion criteria (6 listed)
- Presence of left ventricular hypertrophy (LVH) on echo/CMRI:
- maximal interventricular septal (IVST) and/or posterior wall thickness (PWT) ≥13 mm,
- apical wall thickness ≥15 mm or a ratio of apical to basal LV wall thickness of ≥ 1.3 at end-diastole, OR
- maximal LV wall thickness ≥ 15mm of ANY OTHER PART
- Male and female adult age ≥ 20 year-old
Key exclusion criteria (5 listed)
- Patients refuse or unable to give informed consent
- Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the program
- Co-arctation of the aorta, severe aortic stenosis, or severe LV pressure overload
- Athletic heart
- Non-compaction cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 1 year
Death
1 secondary outcome
CV death
Time frame: 1 year
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 26 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Hypertrophic Cardiomyopathy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jul 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 Taiwan. 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?
Contact Yen-Wen Wu, PhD (+886289667000 ext. 1090, wuyw0502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 year). 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 26 Jul 2024.