Role of ARNi in Ventricular Remodeling in Hypertensive LVH (REVERSE-LVH)
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|ClinicalTrials.gov Identifier: NCT03553810|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertensive Heart Disease||Drug: Entresto Drug: Valsartan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Role of ARNi in Ventricular Remodeling in Hypertensive LVH|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment Arm
Entresto (valsartan/sacubitril) 100mg once a day
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 Name: Valsartan/sacubitril
Active Comparator: Controlled Arm
Valsartan 40mg once a day
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.
- Fibrosis volume [ Time Frame: 52 weeks ]Changes from baseline in fibrosis volume measured on CMR. 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)
- Left ventricular mass measured on CMR [ Time Frame: 52 weeks ]Changes from baseline in left ventricular mass, indexed to body surface area (g/m2).
- Biomarker/biochemistry [ Time Frame: 52 weeks ]Identify potential markers as indicators of cardiac structural effects of ARNi and ARB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553810
|National Heart Centre Singapore||Not yet recruiting|
|Singapore, Singapore, 169609|
|Contact: Calvin WL Chin, MD, PhD|
|Principal Investigator: Calvin WL Chin, MD, PhD|