Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)

2. Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).

3. Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol.

4. Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol.

5. Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet).

6. Study population: Men and Women aged over 65 years (n=1200) meeting the inclusion/exclusion criteria.

7. Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day.

8. Follow up: 3 years.

9. Sample size: a total of 1200 patients should be enrolled in the combination.

10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2019, recruitment will start. Patients enrollment will be performed between November 2019 to November 2020. All patients should be followed up before December 2023.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin

Criteria

Inclusion Criteria:

Men or women aged over 65 years. patients who never took antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg.

Patient who sign the written consent and are able to go to the clinic by him/herself.

Exclusion Criteria:

suspected or confirmed secondary hypertension; taking two or more antihypertensive drugs; patients who never take antihypertensive drugs with a clinic blood pressure over 180/110 mmHg or treated patients with a clinic blood pressure over 160/100 mmHg or patients with a home blood pressure below 130/80 mmHg; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²; severe OSAS; patients who are participating in other clinical trials.