Antihypertensive Treatment in Masked Hypertension

NCT ID: NCT02893358

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2022-03-30

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).

Conditions

Masked Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active treatment

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.

Group Type: ACTIVE_COMPARATOR

Allisartan Isoproxil

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Allisartan Isoproxil

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

Placebo

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Li

OTHER

Sponsor Role: lead

Responsible Party

Yan Li

Professor, Doctor of Medicine, Doctor of Philosophy

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Huang JF, Zhang DY, An DW, Li MX, Liu CY, Feng YQ, Zheng QD, Chen X, Staessen JA, Wang JG, Li Y; ANTI-MASK Investigators. Efficacy of antihypertensive treatment for target organ protection in patients with masked hypertension (ANTI-MASK): a multicentre, double-blind, placebo-controlled trial. EClinicalMedicine. 2024 Jul 18;74:102736. doi: 10.1016/j.eclinm.2024.102736. eCollection 2024 Aug.

Reference Type: DERIVED

PMID: 39091669 (View on PubMed)

Other Identifiers

ANTI-MASK20160830

Identifier Type: -

Identifier Source: org_study_id