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

NCT05165251 | Unknown Phase 4 DMC

• 1 other identifier: PLENISH
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.
2. 2.Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).
3. 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. 4.Objective: To demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients.
5. 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. 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. 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. 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. 9.Sample size: A total of 480 patients should be enrolled in total.
10. 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.

Conditions

Isolated Systolic Hypertension

Keywords

amlodipine; atorvastatin; blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in mean office systolic blood pressure after 12-month treatment from baseline in each group

  Baseline and 12 months

Secondary Outcomes (7)

• Change in mean office diastolic blood pressure after 12-month treatment from baseline in each group

  Baseline and 12 months

• Difference in control rate of clinic and home blood pressure after 12-month treatment in each group

  Baseline and 12 months

• Difference in control rate of ambulatory blood pressure after 12-month treatment in each group

  Baseline and 12 months

• Change in ambulatory (24-h mean, daytime and nighttime) blood pressure after 12-month treatment from baseline in each group

  Baseline and 12 months

• Change in low-density lipoprotein cholesterol after 12-month treatment from baseline in each group

  Baseline and 12 months

Study Arms (3)

Amlodipine/atorvastatin

EXPERIMENTAL

amlodipine/atorvastatin (5mg/10mg QD)

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

Amlodipine

ACTIVE COMPARATOR

amlodipine (5mg QD)

Drug: Amlodipine 5mg

Lifestyle intervention

OTHER

Other: Lifestyle intervention

Interventions

Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET DRUG

Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET QD

Amlodipine/atorvastatin

Amlodipine 5mg DRUG

amlodipine 5mg QD

Amlodipine

Lifestyle intervention OTHER

Lifestyle intervention

Lifestyle intervention

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Isolated Systolic Hypertension

Interventions

Amlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular 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: After screening and run-in period, eligible patients will be randomly assigned into amlodipine/atorvastatin group (amlodipine/atorvastatin 5mg QD) or amlodipine group (amlodipine 5mg QD) or lifestyle intervention only group.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: January 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)