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

February 14, 2023 updated by: Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine

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

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  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, especially in hypertensive patients with atrial fibrillation.
  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 or women aged over 65 years (n=1200) will be screened for atrial fibrillation. Atrial fibrillation 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 will be recruited. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself. Exclusion criteria included: suspected or confirmed secondary hypertension; 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; elderly care patients; or patients who are participating in other clinical trials.
  7. Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine (5 mg/tablet)+ once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
  8. Follow up: Sitting office blood pressures and electrocardiogram should measured by an OMRON device. Medical history should be recorded. Clinical examinations including home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. Patients should be followed up every three months. Before the follow-up, patients should perform a one-week home blood pressure monitoring.
  9. Sample size and statistical analysis: At least 300 eligible patients should be enrolled in each group, and a total of 1200 patients should be enrolled in total. Data will be analyzed by using the SAS software. ANOVA will be used to compare the parameters between groups and the difference between the four groups with the calculation of 95% confidence interval. In addition, a covariance analysis will also be used in the analysis of baseline parameters.
  10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2019, recruitment will start. Patients enrollment will be performed between October 2019 to October 2020. All patients should be followed up before December 2023. Database construction and statistical analysis will be conducted at the same time, appropriate domestic and international conferences will be selected to publish the research results. The main results will be published in international professional medical journals.
  11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive blood pressure and cholesterol control
Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET
amlodipine/atorvastatin (5/20mg tablet) once a day
Drug: Allisartan Isoproxil
allisartan (240mg/tablet) once a day
Active Comparator: Intensive blood pressure and routine cholesterol control
Drug: Allisartan Isoproxil
allisartan (240mg/tablet) once a day
Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET
amlodipine/atorvastatin (5/10mg tablet) once a day
Active Comparator: Routine blood pressure and intensive cholesterol control
Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET
amlodipine/atorvastatin (5/20mg tablet) once a day
Active Comparator: Routine blood pressure and cholesterol control
Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET
amlodipine/atorvastatin (5/10mg tablet) once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined cardiovascular end-point events
Time Frame: 3 years
Fatal and non-fatal stroke, acute MI and cardiovascular death
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 29, 2019

First Submitted That Met QC Criteria

September 29, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPRESSION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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