Response of the Myocardium to Hypertrophic Conditions in the Adult Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-99
SponsorNational Heart Centre Singapore
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiovascular Magnetic Resonance
Other interventionFor the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.
Echocardiogram
Other interventionFor the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
Electrocardiogram
Other interventionTo examine specific function of the heart.
Ambulatory Blood Pressure Monitoring
DeviceA 24-hour test.
Retinal Photography (Optional)
Other interventionThe 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.
Treatment groups
2,000 Participants
are divided into 3 treatment groupsGroup A: Newly Diagnosed Hypertension5 interventions
Group B: Well-Controlled Hypertension5 interventions
Group C: Resistant Essential Hypertension5 interventions
Trial outcomes
Primary outcomes
1
First occurrence of cardiovascular event
Heart failure, Myocardial Infarction, Strokes and Death
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov