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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Masked Hypertension
• Intervention / Treatment: Drug: Allisartan Isoproxil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Placebo Comparator: Placebo; Placebo tablets are identical to the active study drugs, with a similar schedule of administration.	Drug: Placebo; Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24h ambulatory blood pressure		1 year
electrocardiogram	calculating Cornell voltage combination and Sokolow-Lyon index	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

Collaborators and Investigators

• Sponsor: Yan Li

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: microalbuminuria; left ventricular hypertrophy; Allisartan Isoproxil; large arterial stiffness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Masked Hypertension
• Other Study ID Numbers: ANTI-MASK20160830

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No