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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03553810
Other study ID # 2018/2182
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 12, 2019
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source National Heart Centre Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In Singapore, hypertension is very common in the adult population. Hypertensive heart disease is a leading cause of heart failure and cardiovascular death. Current management relies primarily on achieving blood pressure targets. However, the optimal blood pressure goals are controversial and there are inherent difficulties in measuring blood pressure using external devices applied to peripheral arteries. As a result of (usually longstanding) hypertension, the heart thickens (i.e. hypertrophies) to maintain function. Ultimately, HF may occur due to long standing energy deficits, muscle injury/death and diffuse interstitial fibrosis (heart muscle scarring). In an ongoing study (REMODEL, ClinicalTrial.gov Identifier NCT02670031), we have been able to undertake preliminary analyses with respect to factors associated with the development of fibrosis. In this randomize controlled trial, we will be examining a novel therapy that has the potential to induce regression cardiac hypertrophy and fibrosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility Inclusion Criteria: - Increased left ventricular mass on cardiovascular magnetic resonance (based on established local age- and sex-specific CMR ranges) - Essential hypertension Exclusion Criteria: - Known secondary causes of hypertension - Previous intolerance to angiotensin receptor blockers - History of heart failure - Stage IV/V chronic renal disease (eGFR < 30ml/min/1.73m2) - Patients with serum potassium > 5.2 mmol/L (mEg/L) at Visit 1 - History of cardiovascular events (myocardial infarction, strokes and transient ischemic attacks) - Known atrial fibrillation - Being unable to understand or comply with study procedures (including CMR) - History or presence of any other disease with a life expectancy of < 3 years - Pregnant or nursing (lactating) women

Study Design


Intervention

Drug:
Entresto
Entresto (Valsartan/sacubitril) 100mg once a day, up-titrating to 200mg or maximum 400mg to achieve target systolic blood pressure below 140 mmHg, over a duration of 52 weeks. If necessary, amlodipine and/or hydrochlorothiazide may be added to achieve target systolic blood pressure.
Valsartan
Valsartan 40mg once a day, up-titrating to 80 or maximum 160 mg to achieve target systolic blood pressure below 140mmHg, over a duration of 52 weeks. If necessary, amlodipine and/or hydrochlorothiazide may be added to achieve target systolic blood pressure.

Locations

Country Name City State
Singapore National Heart Centre Singapore Singapore

Sponsors (2)

Lead Sponsor Collaborator
National Heart Centre Singapore National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fibrosis volume A difference in terms of change in interstitial volume from baseline following 52 weeks of treatment. Extracellular volume fraction (ECV) will be quantified from native and post-contrast myocardial T1. Fibrosis volume is defined as ECV x myocardial volume and indexed to body surface area (ml/m2) 52 weeks
Secondary Left ventricular mass measured on CMR Changes from baseline in left ventricular mass, indexed to body surface area (g/m2). 52 weeks
Secondary Biomarker/biochemistry Identify potential markers as indicators of cardiac structural effects of ARNi and ARB 52 weeks
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