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The effect of azisartan in combination with homocysteine descent therapy on left ventricular structure and function in patients with H-type hypertension and atrial fibrillation: a randomized, open-label, parallel controlled trial

The effect of azisartan in combination with homocysteine descent therapy on left ventricular structure and function in patients with H-type hypertension and atrial fibrillation: a randomized, open-label, parallel controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070085
Enrollment
Unknown
Registered
2023-04-01
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H type Hypertension with atrial fibrillation

Interventions

Azilsartan Group:Azilsartan 40mg QD PO
Candesartan group:Candesartan 8mg QD PO

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age=18 years old, both sexes, to ensure that no less than one third of the subjects are female; 2) 18.5kg/m2= Body Mass Index (BMI)=30kg/m2 (BMI= weight (kg)/height (m) 2); 3) Diagnosed as essential hypertension with 140= systolic blood pressure(SBP) =180mmHg and/or 90= diastolic blood pressure (DBP) =110mmHg according to the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Hypertension (2018 Revision). 4) Adherence should be 80%-120% (including boundary value) if antihypertensive drugs have been used previously; 5) Diagnosed as atrial fibrillation(AF) according to the diagnostic criteria of Atrial Fibrillation: current understanding and treatment recommendations (2021) and planning to undergo radiofrequency ablation for AF in our department; 6) Serum homocysteine level =15µmol/L 7) Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg 2) Diagnosed as secondary hypertension (including renal parenchymal hypertension, renovascular hypertension, Cushing syndrome, primary aldosteronism, pheochromocytoma, drug-induced hypertension, etc.) 3) Allergic to ARBs 4) Diabetic patients take aliskiren fumarate 5) Paroxysmal atrial fibrillation 6) BMI 30kg/m2 7) Acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or other serious heart disease (such as cardiogenic shock, severe aortic stenosis, and ? degree atrioventricular block) within the past 6 months 8) Severe cerebrovascular disease (cerebrovascular injury, stroke, etc.) in the past 6 months 9) Patients with severe digestive diseases in the past 3 months or gastrointestinal surgery that may affect drug absorption and metabolism, such as gastrointestinal resection, ulcer, or gastrointestinal bleeding. 10) Serum potassium =5.5mmol/L 11) Estimated glomerular filtration rate (eGFR) less than 15mL/min/1.73 m2 12) Severe liver dysfunction (alanine aminotransferase and/or aspartate aminotransferase > 3 times the upper limit of normal, and/or total bilirubin > 1.5 times the upper limit of normal) 13) Severe nephrotic syndrome (albumin 8.5%) 19) Pregnancy or lactation 20) People who often need to carry out night work 21) Already participate clinical trials of other investigational drugs

Design outcomes

Primary

MeasureTime frame
left atrial diameter;

Secondary

MeasureTime frame
Left atrial other structure indicator;Left atrial function;Left ventricular diastolic function;Myocardial fibrosis level;

Countries

China

Contacts

Public ContactXiaotong Wang

The First Affiliated Hospital of Zhejiang University School of Medicine

maliaVV@163.com13505813510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026