Antihypertensive Treatment in Masked Hypertension for Target Organ Protection

Masked Hypertension Clinical Trial

— ANTI-MASK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02893358
• Other study ID #: ANTI-MASK20160830
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 14, 2017
• Est. completion date: October 30, 2021

Study information

• Verified date: September 2021
• Source: Shanghai Institute of Hypertension
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Masked Hypertension

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yan Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24h ambulatory blood pressure		1 year
Secondary	electrocardiogram	calculating Cornell voltage combination and Sokolow-Lyon index	1 year
Secondary	microalbuminuria/creatinine ratio		1 year
Secondary	brachial-ankle pulse wave velocity		1 year
Secondary	incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)		1 year