Reducing Blood Pressure and Lipids in Elderly Patients with Isolated Systolic Hypertension

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

This study is testing if a combination of medications and lifestyle changes can help older adults with high blood pressure feel better and improve their health.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 65 Years to 79 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05165251 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of blood pressure and lipid-lowering therapy in elderly patients with isolated systolic hypertension. It involves a 12-month prospective, randomized, active-controlled, open-label design with three treatment groups: amlodipine/atorvastatin, amlodipine alone, and a lifestyle intervention. The study aims to determine if these treatments can improve health outcomes in older adults who are typically untreated for this condition. Participants will be men and women aged 65 to 79 with specific blood pressure criteria.

Who should consider this trial

Good fit: Ideal candidates are untreated men and women aged 65 to 79 with isolated systolic hypertension.

Not a fit: Patients with severe renal insufficiency, active liver disease, or a history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for elderly patients suffering from isolated systolic hypertension, potentially reducing morbidity and mortality.

How similar studies have performed: While there is limited evidence on the specific combination of treatments in this demographic, similar studies have shown promise in managing hypertension in older adults.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)

Conditions Isolated Systolic Hypertension; amlodipine; atorvastatin; blood pressure