Antihypertensive Treatment in Masked Hypertension for Target Organ Protection

Study Overview
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Brief Summary
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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).

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

Conditions
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Masked Hypertension

Intervention / Treatment
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* Drug: Allisartan Isoproxil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment<br>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. | Drug: Allisartan Isoproxil<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo tablets are identical to the active study drugs, with a similar schedule of administration. | Drug: Placebo<br>* Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h ambulatory blood pressure |  | 1 year | 
| electrocardiogram | calculating Cornell voltage combination and Sokolow-Lyon index | 1 year | 
| microalbuminuria/creatinine ratio |  | 1 year | 
| brachial-ankle pulse wave velocity |  | 1 year | 
| incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria