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Trial record 83 of 99 for:    AMLODIPINE AND VALSARTAN

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
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National Heart Centre Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertensive Heart Disease Drug: Entresto Drug: Valsartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
Experimental: Treatment Arm
Entresto (valsartan/sacubitril) 100mg once a day
Drug: 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.
Other Name: Valsartan/sacubitril

Active Comparator: Controlled Arm
Valsartan 40mg once a day
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Singapore
National Heart Centre Singapore Not yet recruiting
Singapore, Singapore, 169609
Contact: Calvin WL Chin, MD, PhD         
Principal Investigator: Calvin WL Chin, MD, PhD         
Sponsors and Collaborators
National Heart Centre Singapore
National Medical Research Council (NMRC), Singapore

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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03553810     History of Changes
Other Study ID Numbers: 2018/2182
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Diseases
Ventricular Remodeling
Cardiovascular Diseases
Pathological Conditions, Anatomical
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action