Overview

Role of ARNi in Ventricular Remodeling in Hypertensive LVH

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Heart Centre Singapore
Collaborator:
National Medical Research Council (NMRC), Singapore
Treatments:
Hydrochlorothiazide
LCZ 696
Sacubitril and valsartan sodium hydrate drug combination
Valsartan
Criteria
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