Antihypertensive Treatment in Masked Hypertension (ANTI-MASK)

Yan Li

Status and phase: Completed; Phase 4

Conditions: Masked Hypertension

Treatments: Drug: Allisartan Isoproxil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02893358

ANTI-MASK20160830

Details and patient eligibility

About

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).

Enrollment: 320 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups, including a placebo group

Active treatment

Active Comparator group

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.

Treatment:

Drug: Allisartan Isoproxil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo