Response of the Myocardium to Hypertrophic Conditions in the Adult Population

NCT02670031 | Recruiting DMC

• 1 other identifier: 2015/2603
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Left Ventricular Hypertrophy; Hypertension; Myocardial Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• First occurrence of cardiovascular event

  Heart failure, Myocardial Infarction, Strokes and Death

  10 years

Study Arms (3)

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

Cardiovascular Magnetic Resonance OTHER

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.

Newly Diagnosed Hypertension; Resistant Essential Hypertension; Well-Controlled Hypertension

Echocardiogram OTHER

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

Newly Diagnosed Hypertension; Resistant Essential Hypertension; Well-Controlled Hypertension

Electrocardiogram OTHER

To examine specific function of the heart.

Newly Diagnosed Hypertension; Resistant Essential Hypertension; Well-Controlled Hypertension

Ambulatory Blood Pressure Monitoring DEVICE

A 24-hour test.

Newly Diagnosed Hypertension; Resistant Essential Hypertension; Well-Controlled Hypertension

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.

Newly Diagnosed Hypertension; Resistant Essential Hypertension; Well-Controlled Hypertension

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 28847911 BACKGROUND

• Lee 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.

  PMID: 41073114 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from all participants.

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Calvin WL Chin, MBBS, PhD

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu Jie Liew

CONTACT

82002052; liew.mu.jie@nhcs.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)