Role of ARNi in Ventricular Remodeling in Hypertensive LVH (REVERSE-LVH)

Singapore Health Services (SingHealth)

Status and phase: Completed; Phase 2

Conditions: Hypertensive Heart Disease

Treatments: Drug: Entresto; Drug: Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT03553810

2018/2182

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Entresto (valsartan/sacubitril) 100mg once a day

Treatment:

Drug: Entresto

Controlled Arm

Active Comparator group

Description:

Valsartan 40mg once a day

Treatment:

Drug: Valsartan