Clinical trial NCT02893358: Antihypertensive Treatment in Masked Hypertension
Official title: Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Masked Hypertension
Keywords: Allisartan Isoproxil
left ventricular hypertrophy
large arterial stiffness
microalbuminuria
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

1. Age 30-70 years old
2. 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
3. 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).
4. Didn't use any anti-hypertension drugs within 2 weeks
5. Be willing to participate in the trials and able to finish clinic visits

Exclusion Criteria:

1. Under antihypertensive treatment
2. Secondary hypertension
3. Taking other medications that may influence BP
4. Sleep apnea syndrome
5. Diabetes combined with microalbuminuria
6. Renal parenchymal disease, such as chronic nephritis, polycystic kidney
7. Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months
8. Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy
9. 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,
10. Patients have contraindications to angiotensin receptor blockers (ARBs)

Primary outcomes:
measure: Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
timeFrame: 1 year
Secondary outcomes:
measure: 24h ambulatory blood pressure
timeFrame: 1 year
measure: electrocardiogram
timeFrame: 1 year
measure: microalbuminuria/creatinine ratio
timeFrame: 1 year
measure: brachial-ankle pulse wave velocity
timeFrame: 1 year
measure: incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: