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Completed

NCT Number: NCT02893358

Antihypertensive Treatment in Masked Hypertension

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).

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)

    Time frame: 1 year

    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%.

Secondary outcomes

  1. 24h ambulatory blood pressure

    Time frame: 1 year

  2. electrocardiogram

    Time frame: 1 year

    calculating Cornell voltage combination and Sokolow-Lyon index

  3. microalbuminuria/creatinine ratio

    Time frame: 1 year

  4. brachial-ankle pulse wave velocity

    Time frame: 1 year

  5. incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Yan Li

Other

Registry information

Official study title

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

Acronym: ANTI-MASK

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2016
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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