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Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)

Primary Purpose

Masked Hypertension

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Allisartan Isoproxil

Placebo

About this trial

This is an interventional prevention trial for Masked Hypertension focused on measuring Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 30-70 years old
Masked hypertension patients, defined as clinic BP<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg
Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).
Didn't use any anti-hypertension drugs within 2 weeks
Be willing to participate in the trials and able to finish clinic visits

Exclusion Criteria:

Under antihypertensive treatment
Secondary hypertension
Taking other medications that may influence BP
Sleep apnea syndrome
Diabetes combined with microalbuminuria
Renal parenchymal disease, such as chronic nephritis, polycystic kidney
Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months
Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy
Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L,
Patients have contraindications to angiotensin receptor blockers (ARBs)

Sites / Locations

Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active treatment

Placebo

Arm Description

Treatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP<130/80 mmHg, and daytime BP <135/85 mmHg, and nighttime BP <120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil.

Placebo tablets are identical to the active study drugs, with a similar schedule of administration.

Outcomes

Primary Outcome Measures

Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)

Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.

Secondary Outcome Measures

24h ambulatory blood pressure

electrocardiogram

calculating Cornell voltage combination and Sokolow-Lyon index

microalbuminuria/creatinine ratio

brachial-ankle pulse wave velocity

incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)

Full Information

NCT ID

NCT02893358

First Posted

August 31, 2016

Last Updated

September 27, 2021

Sponsor

Yan Li

1. Study Identification

Unique Protocol Identification Number

NCT02893358

Brief Title

Antihypertensive Treatment in Masked Hypertension for Target Organ Protection

Acronym

ANTI-MASK

Official Title

Antihypertensive Treatment in Masked Hypertension for Target Organ Protection(ANTI-MASK)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 14, 2017 (Actual)

Primary Completion Date

October 30, 2021 (Anticipated)

Study Completion Date

October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yan Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%. The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Masked Hypertension

Keywords

Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets are identical to the active study drugs, with a similar schedule of administration.

Intervention Type

Drug

Intervention Name(s)

Allisartan Isoproxil

Intervention Description

Allisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.

Primary Outcome Measure Information:

Title

Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

24h ambulatory blood pressure

Time Frame

1 year

Title

electrocardiogram

Description

calculating Cornell voltage combination and Sokolow-Lyon index

Time Frame

1 year

Title

microalbuminuria/creatinine ratio

Time Frame

1 year

Title

brachial-ankle pulse wave velocity

Time Frame

1 year

Title

incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 30-70 years old Masked hypertension patients, defined as clinic BP<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female). Didn't use any anti-hypertension drugs within 2 weeks Be willing to participate in the trials and able to finish clinic visits Exclusion Criteria: Under antihypertensive treatment Secondary hypertension Taking other medications that may influence BP Sleep apnea syndrome Diabetes combined with microalbuminuria Renal parenchymal disease, such as chronic nephritis, polycystic kidney Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L, Patients have contraindications to angiotensin receptor blockers (ARBs)

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

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Antihypertensive Treatment in Masked Hypertension for Target Organ Protection

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