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OpenTrials
Completed

NCT Number: NCT03553810

Role of ARNi in Ventricular Remodeling in Hypertensive LVH

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.

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Key information

Conditions

Hypertensive Heart Disease

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Heart Centre Singapore

Singapore, 169609

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entresto

Drug

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.

Other names: Valsartan/sacubitril

valsartan

Drug

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.

Primary outcomes

  1. Fibrosis volume

    Time frame: 52 weeks

    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)

Secondary outcomes

  1. Left ventricular mass measured on CMR

    Time frame: 52 weeks

    Changes from baseline in left ventricular mass, indexed to body surface area (g/m2).

  2. Biomarker/biochemistry

    Time frame: 52 weeks

    Identify potential markers as indicators of cardiac structural effects of ARNi and ARB

Sponsors and collaborators

Lead sponsor

National Heart Centre Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Acronym: REVERSE-LVH

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2018
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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