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

NCT04111419 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: IMPRESSION
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)
2. 2.Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).
3. 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. 4.Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol.
5. 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. 6.Study population: Men and Women aged over 65 years (n=1200) meeting the inclusion/exclusion criteria.
7. 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. 8.Follow up: 3 years.
9. 9.Sample size: a total of 1200 patients should be enrolled in the combination.
10. 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.

Conditions

Atrial Fibrillation; Hypertension

Keywords

intensive management; blood pressure; blood cholesterol

Outcome Measures

Primary Outcomes (1)

• Combined cardiovascular end-point events

  Fatal and non-fatal stroke, acute MI and cardiovascular death

  3 years

Study Arms (4)

Intensive blood pressure and cholesterol control

EXPERIMENTAL

Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET; Drug: Allisartan Isoproxil

Intensive blood pressure and routine cholesterol control

ACTIVE COMPARATOR

Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET; Drug: Allisartan Isoproxil

Routine blood pressure and intensive cholesterol control

ACTIVE COMPARATOR

Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET

Routine blood pressure and cholesterol control

ACTIVE COMPARATOR

Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET

Interventions

Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET DRUG

amlodipine/atorvastatin (5/20mg tablet) once a day

Intensive blood pressure and cholesterol control; Routine blood pressure and intensive cholesterol control

Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET DRUG

amlodipine/atorvastatin (5/10mg tablet) once a day

Intensive blood pressure and routine cholesterol control; Routine blood pressure and cholesterol control

Allisartan Isoproxil DRUG

allisartan (240mg/tablet) once a day

Intensive blood pressure and cholesterol control; Intensive blood pressure and routine cholesterol control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Amlodipine; Atorvastatin; allisartan isoproxil

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 1, 2019
• Study Start: July 1, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)