Role of ARNi in Ventricular Remodeling in Hypertensive LVH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2024-06-28

Brief Summary

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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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Detailed Description

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Conditions

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Hypertensive Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Arm

Entresto (valsartan/sacubitril) 100mg once a day

Group Type EXPERIMENTAL

Entresto

Intervention Type 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.

Controlled Arm

Valsartan 40mg once a day

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Valsartan/sacubitril

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No