Antihypertensive Treatment in Masked Hypertension

NCT02893358 | Completed Phase 4

• 1 other identifier: ANTI-MASK20160830
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 24h ambulatory blood pressure

  1 year

• electrocardiogram

  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

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Allisartan Isoproxil 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.

Active treatment

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yan Li: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 39091669 DERIVED

MeSH Terms

Conditions

Masked Hypertension; Hypertrophy, Left Ventricular

Interventions

allisartan isoproxil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor of Medicine, Doctor of Philosophy

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 8, 2016
• Study Start: February 14, 2017
• Primary Completion: October 30, 2021
• Study Completion: March 30, 2022
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)