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

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ClinicalTrials.gov Identifier: NCT02893358
Recruitment Status : Unknown
Verified September 2016 by Yan Li, Shanghai Institute of Hypertension.
Recruitment status was:  Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Yan Li, Shanghai Institute of Hypertension

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).


Condition or disease Intervention/treatment Phase
Masked Hypertension Drug: Allisartan Isoproxil Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893358


Contacts
Contact: Yan Li, Professor 021-64370045 ext 663228 liyanshcn@yahoo.com

Locations
China, Shanghai
Ruijin Hospital Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Yan Li, Professor    021-64370045 ext 663228    liyanshcn@yahoo.com   
Principal Investigator: Yan Li, Professor         
Sponsors and Collaborators
Yan Li

Responsible Party: Yan Li, Professor, Doctor of Medicine, Doctor of Philosophy, Shanghai Institute of Hypertension
ClinicalTrials.gov Identifier: NCT02893358     History of Changes
Other Study ID Numbers: ANTI-MASK20160830
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Yan Li, Shanghai Institute of Hypertension:
Allisartan Isoproxil
left ventricular hypertrophy
large arterial stiffness
microalbuminuria

Additional relevant MeSH terms:
Hypertension
Masked Hypertension
Vascular Diseases
Cardiovascular Diseases