Hypertension,Essential, Hyperuricemia
Conditions
Keywords
Hypertension, Hyperuricemia, Non-inferiority
Brief summary
This clinical trial aims to evaluate the non-inferiority of Aliskiren compared to Losartan in the treatment of hypertension combined with hyperuricemia. Hypertension and hyperuricemia often coexist and may exacerbate each other, increasing the risk of cardiovascular and renal complications. Both Aliskiren and Losartan are widely used for managing hypertension, but their effects on serum uric acid levels and renal function are not well understood in this patient population. This study will involve 66 participants, randomly assigned to receive either Aliskiren (240 mg daily) or Losartan (100 mg daily) for a treatment period of 3 months. The primary outcome will be the change in serum uric acid levels before and after treatment. Secondary outcomes include changes in blood pressure, kidney function (measured by creatinine levels, eGFR), and adverse events. The primary objective is to demonstrate that Aliskiren is non-inferior to Losartan in lowering serum uric acid levels. Additionally, the study will assess whether Aliskiren, while effectively managing blood pressure, has a lesser impact on kidney function compared to Losartan.
Interventions
DRUGAliskiren
Participants in this group will receive Aliskiren (240 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be administered orally once a day for 3 months. The drug will be provided by Shenzhen Xinlitai Pharmaceutical Co., Ltd., with the National Drug Approval No. H20138002. The primary objective is to evaluate the non-inferiority of Aliskiren in lowering serum uric acid levels, and its effects on blood pressure and kidney function.
DRUGLosartan
Participants in this group will receive Losartan (100 mg daily) for the treatment of hypertension combined with hyperuricemia. The medication will be administered orally once a day for 3 months. The drug will be provided by Zhejiang Huahai Pharmaceutical Co., Ltd., with the National Drug Approval No. H20143030. The goal is to compare the efficacy of Losartan in reducing serum uric acid levels with Aliskiren and evaluate its impact on blood pressure and kidney function.
Sponsors
Hansung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with Hypertension 2. Diagnosed with Hyperuricemia 3. Serum uric acid levels between 420 μmol/L and 700 μmol/L 4. Age between 18 and 80 years 5. Able to provide informed consent 6. No history of gout 7. No serious comorbidities such as severe kidney, liver, or cardiovascular diseases
Exclusion criteria
1. Diagnosis of Gout 2. History of secondary hypertension 3. Severe organ dysfunction, including liver, kidney, or heart failure 4. History of malignant tumors 5. Severe cognitive disorders or mental illness 6. Pregnant or breastfeeding women 7. Allergy to study medications (Aliskiren or Losartan) 8. Participation in other clinical trials during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Uric Acid Levels | Baseline (before treatment) and 3 months | The primary outcome measure is the change in serum uric acid levels from baseline to the end of treatment (3 months) in both the Aliskiren and Losartan treatment groups. Serum uric acid levels will be measured using the uricase method from 5 mL fasting venous blood samples before and after treatment. This measure will assess the non-inferiority of Aliskiren compared to Losartan in lowering serum uric acid levels in patients with hypertension and hyperuricemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | Baseline (before treatment) and 3 months | The secondary outcome measure is the change in blood pressure (systolic and diastolic) from baseline to the end of treatment (3 months). Blood pressure will be measured using a sphygmomanometer after the participant has rested for at least 5 minutes, with three measurements taken at 1-minute intervals and the average value used. |
| Change in Kidney Function | Baseline (before treatment) and 3 months | Change in Kidney Function The secondary outcome measure is the change in kidney function, creatinine (Cr) ， from baseline to the end of treatment (3 months). |
Countries
China
Outcome results
None listed