Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension

Isolated Systolic Hypertension Clinical Trial

Official title:

Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165251
• Other study ID #: PLENISH
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.

2. Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).

3. Rationale: Because of its extremely high prevalence in older adults, hypertension is a leading cause of preventable morbidity and mortality. Both SBP and DBP increase linearly up to the fifth or sixth decade of life, after which DBP gradually decreases while SBP continues to rise. Thus, isolated systolic hypertension (ISH) is the predominant form of hypertension in older persons. But there's still no evidence whether elderly ISH patients would benefit from blood pressure and lipid lowering therapy.

4. Objective: To demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients.

5. Study design: This is a 12-month prospective, randomized, active-controlled, apen-label, multi-center study, with three treatment groups: amlodipine/atorvastatin (5mg/10mg tablet); amlodipine (5mg tablet) and lifestyle intervention.

6. Study population: Men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated patients with isolated systolic hypertension (clinic systolic blood pressure ≥ 130 and < 150mmHg), and diastolic blood pressure <80 mmHg). Patients should have abilities to understand the study requirements and provide informed consent.

7. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 3 groups, taking one pill of amlodipine/atorvastatin (5mg/10mg tablet) or amlodipine (5mg tablet) or lifestyle intervention only.

8. Follow-up: After meeting the inclusion criteria, there will be 2-week screening period. Clinic blood pressure, ambulatory blood pressure, home blood pressure, electrocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into amlodipine/atorvastatin group and amlodipine group and lifestyle only group. The treatment will be observed for 12 months. There will be 6 visiting points in the treatment period, which will be the 1st month, 2nd month, 3rd month, 6th month, 9th month and 12th month.

9. Sample size: A total of 480 patients should be enrolled in total.

10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in October 2021, recruitment will start. Patients enrollment and follow-up will be performed between January 2022 to December 2023.

Description:

1. Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.

2. Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).

3. Rationale: Because of its extremely high prevalence in older adults, hypertension is a leading cause of preventable morbidity and mortality. Both SBP and DBP increase linearly up to the fifth or sixth decade of life, after which DBP gradually decreases while SBP continues to rise. Thus, isolated systolic hypertension (ISH) is the predominant form of hypertension in older persons. But there's still no evidence whether elderly ISH patients would benefit from blood pressure and lipid lowering therapy.

4. Objective: to demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients.

5. Study design: This is a 12-month prospective, randomized, active-controlled, apen-label, multi-center study, with three treatment groups: amlodipine/atorvastatin (5mg/10mg tablet); amlodipine (5mg tablet) and lifestyle intervention.

6. Study population: men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated patients with isolated systolic hypertension (clinic systolic blood pressure ≥ 130 and < 150mmHg), and diastolic blood pressure <80 mmHg). Patients should have abilities to understand the study requirements and provide informed consent.

7. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 3 groups, taking one pill of amlodipine/atorvastatin (5mg/10mg tablet) or amlodipine (5mg tablet) or lifestyle intervention only.

8. Follow up: after meeting the inclusion criteria, there will be 2-week screening period. Clinic blood pressure, ambulatory blood pressure, home blood pressure, electrocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into amlodipine/atorvastatin group and amlodipine group and lifestyle only group. The treatment will be observed for 12 months. There will be 6 visiting points in the treatment period, which will be the 1st month, 2nd month, 3rd month, 6th month, 9th month and 12th month.

9. Sample size: A total of 480 patients should be enrolled in total.

10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in October 2021, recruitment will start. Patients enrollment and follow-up will be performed between January 2022 to December 2023.

11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

Inclusion Criteria:

• Aged 65-79;

• Isolated systolic hypertension (office systolic blood pressure (SBP) = 130 and < 150 mmHg and office diastolic blood pressure (DBP) < 80 mmHg) in untreated patients;

• Ability to understand the study requirements and provide informed consent.

Exclusion Criteria:

• Hypersensitivity history to any study drug or similar drug;

• Severe renal insufficiency (eGFR < 30 mL/min/1.73m2);

• Hyperkalemia (serum potassium > 5mmol/L);

• Active liver disease or hepatic insufficiency (AST or ALT > 3 times upper limit of normal);

• History of malignancy over the past 5 years;

• Severe disease patients with life expectancy of < 1 year;

• Previous or current diagnosis of heart failure;

• Stroke or myocardial infarction within 6 months;

• Previous or current atrial fibrillation, frequent ventricular premature beats, supraventricular tachycardia;

• Patients who are receiving other study drugs or study medical devices;

• Pregnant or lactating women;

• Other circumstances that patients are not appropriate for the study upon the investigator's judgment.

Related Conditions & MeSH terms

• Hypertension
• Isolated Systolic Hypertension
• Systolic Murmurs

Intervention

Drug:
• Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET
Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET QD
• Amlodipine 5mg
amlodipine 5mg QD

Other:
• Lifestyle intervention
Lifestyle intervention

Locations

Country	Name	City	State
China	Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean office systolic blood pressure after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in mean office diastolic blood pressure after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Difference in control rate of clinic and home blood pressure after 12-month treatment in each group		Baseline and 12 months
Secondary	Difference in control rate of ambulatory blood pressure after 12-month treatment in each group		Baseline and 12 months
Secondary	Change in ambulatory (24-h mean, daytime and nighttime) blood pressure after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in low-density lipoprotein cholesterol after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in clinic, ambulatory and home mean blood pressure after 6-month treatment from baseline in each group		Baseline and 6 months
Secondary	Difference in control rate of clinic, ambulatory and home blood pressure after 6-month treatment in each group		Baseline and 6 months