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RecruitingNCT02670031Updated Aug 2, 2023

Response of the Myocardium to Hypertrophic Conditions in the Adult Population

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
21 Years to 99 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Left Ventricular Hypertrophy
  • Hypertension
  • Myocardial Fibrosis

Keywords

  • Hypertensive Heart Disease
  • Hypertension
  • Left Ventricular Hypertrophy
  • Myocardial Fibrosis
  • Cardiovascular Magnetic Resonance Imaging
03

In context

Hypertrophy, Left Ventricular

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 →

Lead sponsor

National Heart Centre Singapore is the lead sponsor of 63 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  1. 21 years and over
  2. Physician diagnosed essential hypertension, on at least 1 medication for blood pressure control
  3. 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
  4. 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)

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. 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
  3. Limited
  4. On-going unstable medical conditions: hypertensive crisis, acute coronary syndromes or acute heart failure
  5. History of coronary artery disease, ischemic heart disease
  6. History of or cerebrovascular events
  7. History of atrial fibrillation
  8. History of heart failure
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Newly Diagnosed Hypertension

    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)

  • Well-Controlled Hypertension

    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)

  • Resistant Essential Hypertension

    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)

Interventions

  • OtherCardiovascular Magnetic Resonance

    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.

  • OtherEchocardiogram

    For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.

  • OtherElectrocardiogram

    To examine specific function of the heart.

  • DeviceAmbulatory Blood Pressure Monitoring

    A 24-hour test.

  • OtherRetinal 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.

06

What researchers measure

Primary outcomes

  1. First occurrence of cardiovascular event

    Heart failure, Myocardial Infarction, Strokes and Death

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 28847911 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02670031
Lead sponsor
National Heart Centre Singapore
Responsible party
Sponsor
First posted
Feb 1, 2016
Start date
Jan 2016
Primary completion
Sep 2031 (estimated)
Completion
Sep 2031 (estimated)
Last update
Aug 2, 2023

Study contacts

Mu Jie Liew
Contact
liew.mu.jie@nhcs.com.sg
82002052 ext. 67042304
Calvin WL Chin, MBBS, PhD
principal investigator · National Heart Centre Singapore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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