Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Conditions
Brief summary
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (\>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
Interventions
DIETARY_SUPPLEMENTSodium
50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years; 2. diagnosed as PA by SIT; 3. no lateralization of aldosterone secretion during AVS; 4. serum potassium ≥ 2.8 mmol/L after the stage I.
Exclusion criteria
1. Impaired renal function (Ccr\<60 ml/min); 2. Impaired liver function (ALT, AST \> 2.5 times upper limit of normal); 3. Patients with heart failure (NYHA≥ class 3 or EF \< 50%); 4. Patients with stroke or acute infarction in the last 6 months; 5. Patients who are pregnant or breastfeeding; 6. Patients who cannot tolerate dietary arrangements; 7. Patients with history of malignant tumors in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. | 2 weeks |
Countries
China
Outcome results
None listed