The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Treatments: Dietary Supplement: Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05649631

Ruijin-2020-294

Details and patient eligibility

About

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Normal sodium diet(100mmol/d)

Experimental group

Treatment:

Dietary Supplement: Sodium

Low sodium diet(50mmol/d)

Experimental group

Treatment:

Dietary Supplement: Sodium