An observational study in Left Ventricular Hypertrophy, Hypertension and Myocardial Fibrosis, sponsored by National Heart Centre Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by National Heart Centre Singapore · Observational
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.
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →National Heart Centre Singapore is the lead sponsor of 63 studies on the registry; 18 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo the following studying procedures: electrocardiogram, echocardiogram, cardiovascular magnetic resonance imaging and 24-hr ambulatory blood pressure monitoring.
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.
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.
Other: Cardiovascular Magnetic Resonance · Other: Echocardiogram · Other: Electrocardiogram · Device: Ambulatory Blood Pressure Monitoring · Other: Retinal Photography (Optional)
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.
For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
To examine specific function of the heart.
A 24-hour test.
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.
First occurrence of cardiovascular event
Heart failure, Myocardial Infarction, Strokes and Death
Time frame: 10 years
Plan to share: No
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Hypertrophy, Left Ventricular →
National Heart Centre Singapore