Left Ventricular HypertrophyNCT02670031
Response of the Myocardium to Hypertrophic Conditions in the Adult Population
An observational study of Left Ventricular Hypertrophy and Hypertension, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Hypertension and aortic stenosis are the two leading conditions that cause thickening of the heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially adaptive to maintain optimal heart function. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Hypertrophy, Hypertension, Myocardial Fibrosis
- What is being tested?
- Cardiovascular Magnetic Resonance, Echocardiogram and Electrocardiogram
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2016to Sep 2031
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore. In addition, they will be recruited through posters and advertisements.
Who may be able to join
- 21 years and over
- Physician diagnosed essential hypertension, on at least 1 medication for blood pressure control
- Newly diagnosed hypertension: systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) on at least 2 office visits (Weber 2013) and not started on any anti hypertensive medications at time of ambulatory blood pressure monitoring
- Resistant hypertension: persistent systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) despite on at least 3 anti-hypertensive medications (Jennings 2013; Weber 2013)
Who cannot join
- Known secondary hypertension: renal causes (renal artery stenosis, chronic renal failure); endocrine causes (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism); cardiac causes (coarctation of the aorta)
- Contraindications to cardiovascular magnetic resonance: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and women who are pregnant or breast-feeding
- Limited life expectancy
- On-going unstable medical conditions: hypertensive crisis, acute coronary syndromes or acute heart failure
- History of coronary artery disease, ischemic heart disease
- History of transient ischemic attacks or cerebrovascular events
- History of atrial fibrillation
- History of heart failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
About this study
Hypertension and aortic stenosis are the two leading conditions that cause thickening of the heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin blood assays are potential markers to detect myocardial fibrosis. Although hypertension-related heart disease is very common in Singapore, the significance of myocardial fibrosis is not well understood. In this study, the significance of myocardial fibrosis in 2000 patients with hypertension would be investigated. This will be the largest study using state-of-the-art MRI to examine the importance of myocardial fibrosis in hypertensive heart disease. 1000 participants, with at least 1 year follow-up, will be invited for a repeat assessment.
Read the detailed description
According to the National Health Survey in 2010, more than 50% of adults between 60-69 years old in Singapore had hypertension. As the population ages and life expectancy continues to increase, an increasing incidence of hypertensive heart disease would be expected. Similar to aortic stenosis, left ventricular hypertrophy in patients with hypertension was associated with adverse cardiovascular outcome, independent of traditional risk factors including peripheral blood pressure. Unlike aortic stenosis (a condition with fixed obstruction), arterial hypertension is dynamic and with effective medical therapy, left ventricular hypertrophy can regress and outcome will improve. As such, contemporary guidelines recommend more aggressive blood pressure control in patients with hypertension and left ventricular hypertrophy. However, the correlation between arterial pressure and left ventricular mass is weak, particularly in treated individuals. Coupled with the inherent limitations of measuring peripheral blood pressure, it is clear that using arterial pressure to monitor progression or assess treatment response in patients with hypertensive heart disease is not optimal.
Without timely and appropriate therapies, left ventricular hypertrophy will become progressively maladaptive and ultimately the heart fails. Whilst heart failure is more commonly known by the signs and symptoms related to impaired systolic ejection fraction, heart failure with preserved ejection fraction is an increasingly recognized complex entity characterized by signs and symptoms of heart failure in the presence of preserved ejection fraction. To date, therapies that improve outcomes in heart failure with reduced ejection fraction have not shown similar benefits in patients with heart failure and preserved ejection fraction. There is no single explanation for these negative findings, but one potential reason may relate to the heterogeneity of patients recruited into these trials, and thus supporting a more targeted approach to specific phenotypes rather than a standard treatment strategy for all patients.
Therefore, a focus on the transition from compensatory left ventricular hypertrophy to ventricular decompensation is crucial not only in furthering our understanding of the pathophysiology of hypertensive heart disease, but also instrumental in designing future trials. Small studies had reported replacement myocardial fibrosis in patients with hypertension. But these studies were small and unable to establish determinants associated with myocardial fibrosis. Unlike the increasing evidence of myocardial fibrosis in aortic stenosis, the prognosis associated with myocardial fibrosis in patients with hypertension is currently not known. Although there is promising data suggesting regression in myocardial fibrosis with certain antihypertensive therapies, the effects of myocardial fibrosis regression on long-term outcome is not known. As discussed earlier, other than relying on peripheral blood pressure, there are no biomarkers to monitor response of antihypertensive therapy on regression of left ventricular mass and myocardial fibrosis.
Our investigators would establish a paradigm to demonstrate the significance of myocardial fibrosis in hypertensive heart disease; and examine other biomarkers associated with myocardial fibrosis and myocyte death that have high potential of translating into clinical application to monitor treatment response. Subsequently, the prognosis associated with myocardial fibrosis will be examined in future follow-up studies. In parallel, we will also study the effects of novel agents on the regression of left ventricular hypertrophy and myocardial fibrosis, as well as, long-term clinical outcomes in future studies.
- Being tested
- Cardiovascular Magnetic Resonance, Echocardiogram, Electrocardiogram, Ambulatory Blood Pressure Monitoring, Retinal Photography (Optional)
- Keywords
- Hypertensive Heart Disease, Hypertension, Left Ventricular Hypertrophy, Myocardial Fibrosis, Cardiovascular Magnetic Resonance Imaging
- Medical subject headings
- Hypertrophy, Left Ventricular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceOther
For the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.
EchocardiogramOther
For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
ElectrocardiogramOther
To examine specific function of the heart.
Ambulatory Blood Pressure MonitoringDevice
A 24-hour test.
Retinal Photography (Optional)Other
The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed Hypertension | Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. Receives: Other: Cardiovascular Magnetic Resonance; Other: Echocardiogram; Other: Electrocardiogram; Device: Ambulatory Blood Pressure Monitoring; Other: Retinal Photography (Optional) | |
| Well-Controlled Hypertension | Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. Receives: Other: Cardiovascular Magnetic Resonance; Other: Echocardiogram; Other: Electrocardiogram; Device: Ambulatory Blood Pressure Monitoring; Other: Retinal Photography (Optional) | |
| Resistant Essential Hypertension | Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. Receives: Other: Cardiovascular Magnetic Resonance; Other: Echocardiogram; Other: Electrocardiogram; Device: Ambulatory Blood Pressure Monitoring; Other: Retinal Photography (Optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event
Heart failure, Myocardial Infarction, Strokes and Death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular HypertrophyStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Calvin WL Chin, MBBS, PhD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670031
- Sponsor's protocol ID
- 2015/2603
- Status last verified
- Jul 2023
- First submitted
- 22 Jan 2016
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Goh VJ, Le TT, Bryant J, Wong JI, Su B, Lee CH, Pua CJ, Sim CPY, Ang B, Aw TC, Cook SA, Chin CWL. Novel Index of Maladaptive Myocardial Remodeling in Hypertension. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006840. doi: 10.1161/CIRCIMAGING.117.006840.
PubMed 28847911Lee V, Puar T, Kui MS, Bryant JA, Han Y, Latib AB, Tay W, Kong SC, Toh DF, Boubertakh R, Lee CH, Le TT, Chin CWL. Response of the myocardium to hypertrophic conditions in the adult population (REMODEL): protocol for a prospective observational cohort study. BMJ Open. 2025 Oct 10;15(10):e100932. doi: 10.1136/bmjopen-2025-100932.
PubMed 41073114
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of the Myocardium to Hypertrophic Conditions in the Adult Population
- ClinicalTrials.gov ID
- NCT02670031
- Acronym / sponsor ID
- 2015/2603
- Keywords
- Hypertensive Heart Disease, Hypertension, Left Ventricular Hypertrophy, Myocardial Fibrosis, Cardiovascular Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- 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.
Hypertension and aortic stenosis are the two leading conditions that cause thickening of the heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin blood assays are potential markers to detect myocardial fibrosis. Although hypertension-related heart disease is very common in Singapore, the significance of myocardial fibrosis is not well understood. In this study, the significance of myocardial fibrosis in 2000 patients with hypertension would be investigated. This will be the largest study using state-of-the-art MRI to examine the importance of myocardial fibrosis in hypertensive heart disease. 1000 participants, with at least 1 year follow-up, will be invited for a repeat assessment.
Detailed description
According to the National Health Survey in 2010, more than 50% of adults between 60-69 years old in Singapore had hypertension. As the population ages and life expectancy continues to increase, an increasing incidence of hypertensive heart disease would be expected. Similar to aortic stenosis, left ventricular hypertrophy in patients with hypertension was associated with adverse cardiovascular outcome, independent of traditional risk factors including peripheral blood pressure. Unlike aortic stenosis (a condition with fixed obstruction), arterial hypertension is dynamic and with effective medical therapy, left ventricular hypertrophy can regress and outcome will improve. As such, contemporary guidelines recommend more aggressive blood pressure control in patients with hypertension and left ventricular hypertrophy. However, the correlation between arterial pressure and left ventricular mass is weak, particularly in treated individuals. Coupled with the inherent limitations of measuring peripheral blood pressure, it is clear that using arterial pressure to monitor progression or assess treatment response in patients with hypertensive heart disease is not optimal.
Without timely and appropriate therapies, left ventricular hypertrophy will become progressively maladaptive and ultimately the heart fails. Whilst heart failure is more commonly known by the signs and symptoms related to impaired systolic ejection fraction, heart failure with preserved ejection fraction is an increasingly recognized complex entity characterized by signs and symptoms of heart failure in the presence of preserved ejection fraction. To date, therapies that improve outcomes in heart failure with reduced ejection fraction have not shown similar benefits in patients with heart failure and preserved ejection fraction. There is no single explanation for these negative findings, but one potential reason may relate to the heterogeneity of patients recruited into these trials, and thus supporting a more targeted approach to specific phenotypes rather than a standard treatment strategy for all patients.
Therefore, a focus on the transition from compensatory left ventricular hypertrophy to ventricular decompensation is crucial not only in furthering our understanding of the pathophysiology of hypertensive heart disease, but also instrumental in designing future trials. Small studies had reported replacement myocardial fibrosis in patients with hypertension. But these studies were small and unable to establish determinants associated with myocardial fibrosis. Unlike the increasing evidence of myocardial fibrosis in aortic stenosis, the prognosis associated with myocardial fibrosis in patients with hypertension is currently not known. Although there is promising data suggesting regression in myocardial fibrosis with certain antihypertensive therapies, the effects of myocardial fibrosis regression on long-term outcome is not known. As discussed earlier, other than relying on peripheral blood pressure, there are no biomarkers to monitor response of antihypertensive therapy on regression of left ventricular mass and myocardial fibrosis.
Our investigators would establish a paradigm to demonstrate the significance of myocardial fibrosis in hypertensive heart disease; and examine other biomarkers associated with myocardial fibrosis and myocyte death that have high potential of translating into clinical application to monitor treatment response. Subsequently, the prognosis associated with myocardial fibrosis will be examined in future follow-up studies. In parallel, we will also study the effects of novel agents on the regression of left ventricular hypertrophy and myocardial fibrosis, as well as, long-term clinical outcomes in future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Hypertension | – | Other: Cardiovascular Magnetic Resonance, Other: Echocardiogram, Other: Electrocardiogram, Device: Ambulatory Blood Pressure Monitoring, Other: Retinal Photography (Optional)Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. |
| Well-Controlled Hypertension | – | Other: Cardiovascular Magnetic Resonance, Other: Echocardiogram, Other: Electrocardiogram, Device: Ambulatory Blood Pressure Monitoring, Other: Retinal Photography (Optional)Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. |
| Resistant Essential Hypertension | – | Other: Cardiovascular Magnetic Resonance, Other: Echocardiogram, Other: Electrocardiogram, Device: Ambulatory Blood Pressure Monitoring, Other: Retinal Photography (Optional)Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore. In addition, they will be recruited through posters and advertisements.
Key inclusion criteria (4 listed)
- 21 years and over
- Physician diagnosed essential hypertension, on at least 1 medication for blood pressure control
- Newly diagnosed hypertension: systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) on at least 2 office visits (Weber 2013) and not started on any anti hypertensive medications at time of ambulatory blood pressure monitoring
- Resistant hypertension: persistent systolic blood pressure 140mmHg or greater (diastolic blood pressure 90mmHg or greater) despite on at least 3 anti-hypertensive medications (Jennings 2013; Weber 2013)
Key exclusion criteria (8 listed)
- Known secondary hypertension: renal causes (renal artery stenosis, chronic renal failure); endocrine causes (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism); cardiac causes (coarctation of the aorta)
- Contraindications to cardiovascular magnetic resonance: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and women who are pregnant or breast-feeding
- Limited life expectancy
- On-going unstable medical conditions: hypertensive crisis, acute coronary syndromes or acute heart failure
- History of coronary artery disease, ischemic 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 |
|---|---|---|
| Cardiovascular Magnetic ResonanceFor the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique. | Other | Newly Diagnosed Hypertension, Resistant Essential Hypertension, Well-Controlled Hypertension |
| EchocardiogramFor the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed. | Other | Newly Diagnosed Hypertension, Resistant Essential Hypertension, Well-Controlled Hypertension |
| ElectrocardiogramTo examine specific function of the heart. | Other | Newly Diagnosed Hypertension, Resistant Essential Hypertension, Well-Controlled Hypertension |
| Ambulatory Blood Pressure MonitoringA 24-hour test. | Device | Newly Diagnosed Hypertension, Resistant Essential Hypertension, Well-Controlled Hypertension |
| Retinal Photography (Optional)The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye. | Other | Newly Diagnosed Hypertension, Resistant Essential Hypertension, Well-Controlled Hypertension |
Primary outcome
First occurrence of cardiovascular event
Time frame: 10 years
Heart failure, Myocardial Infarction, Strokes and Death
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 2 Aug 2023.
- Background: PubMed 28847911Goh VJ, Le TT, Bryant J, Wong JI, Su B, Lee CH, Pua CJ, Sim CPY, Ang B, Aw TC, Cook SA, Chin CWL. Novel Index of Maladaptive Myocardial Remodeling in Hypertension. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006840. doi: 10.1161/CIRCIMAGING.117.006840.
- Derived from this study: PubMed 41073114Lee V, Puar T, Kui MS, Bryant JA, Han Y, Latib AB, Tay W, Kong SC, Toh DF, Boubertakh R, Lee CH, Le TT, Chin CWL. Response of the myocardium to hypertrophic conditions in the adult population (REMODEL): protocol for a prospective observational cohort study. BMJ Open. 2025 Oct 10;15(10):e100932. doi: 10.1136/bmjopen-2025-100932.
- 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.
Calvin WL Chin, MBBS, PhD principal investigator
National Heart Centre Singapore
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 Left Ventricular Hypertrophy and Hypertension, run by National Heart Centre Singapore at 1 site 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 4 inclusion and 8 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 2 Aug 2023. 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 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?
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 Mu Jie Liew (82002052 ext. 67042304, liew.mu.jie@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of cardiovascular event (time frame: 10 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 NCT02670031, which also lists 2 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 2 Aug 2023.