The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Shanghai Jiao Tong University School of Medicine50 enrolled

Overview

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet

Time frame: 2 weeks

Secondary Outcomes

The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.