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Completed
NCT05649631
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 50
Sponsor: Shanghai Jiao Tong University School of Medicine
Location: China
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Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
Eligibility Criteria
Inclusion Criteria:18-70 years;diagnosed as PA by SIT;no lateralization of aldosterone secretion during AVS;serum potassium ≥ 2.8 mmol/L after the stage I.Exclusion Criteria:Impaired renal function (Ccr<60 ml/min);Impaired liver function (ALT, AST > 2.5 times upper limit of normal);Patients with heart failure (NYHA≥ class 3 or EF < 50%);Patients with stroke or acute infarction in the last 6 months;Patients who are pregnant or breastfeeding;Patients who cannot tolerate dietary arrangements;Patients with history of malignant tumors in the last 6 months.
Source: ClinicalTrials.gov (NCT05649631). StuddyBuddy aggregates publicly available trial information.
