Masked Hypertension
Conditions
Keywords
Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria
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).
Interventions
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.
DRUGPlacebo
Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.
Sponsors
Yan Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria) | 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
| Measure | Time frame | Description |
|---|---|---|
| 24h ambulatory blood pressure | 1 year | — |
| electrocardiogram | 1 year | calculating Cornell voltage combination and Sokolow-Lyon index |
| 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 | — |
Countries
China
Outcome results
None listed