Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-65
SponsorThird Military Medical University
About this trial
The goal of this observational study is to learn about the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events in patients with lateralized PA who are unwilling to undergo surgery. The main question it aims to answer is:
1. What is the long-term effect of spironolactone treatment for lateralized PA? 2. What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 30~65 years.
PA patients with positive screening tests and saline suppression tests, and with AVS to determine lateralization. These patients have hypertension defined as office blood pressure ≥ 140/90 mmHg, or 24-hour ambulatory blood pressure showing average ≥ 130/80 mmHg, daytime blood pressure ≥ 135/85 mmHg, or nighttime blood pressure ≥ 120/70 mmHg.
Patients with unilateral aldosterone-producing adenoma who decline surgery, or patients with non-adenoma, unilateral PA confirmed by AVS and meeting the above PA-related hypertension criteria.
Provision of written informed consent to participate in the study.
Disqualifiers
Hyperkalemia.
Renal impairment or have history of renal disease: serum creatinine > 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
Adrenal insufficiency.
Trial population
Chinese
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
spironolactone
DrugThe patients receive spironolactone treatment based on their conditions
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Unilateral primary aldosteronism group1 intervention
Trial outcomes
Primary outcomes
1
Change of systolic blood pressure
This study will gain insight into the effect of spironolactone treatment on systolic blood pressure. The systolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of systolic blood pressure are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.2
Change of diastolic blood pressure
This study will gain insight into the effect of spironolactone treatment on diastolic blood pressure. The diastolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of diastolic blood pressure are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.Secondary outcomes
1
Change of anti-hypertensive regimen
This study will gain insight into the effect of spironolactone treatment on anti-hypertensive regimen. The anti-hypertensive regimens are measured before and after spironolactone treatment, respectively. The changes of anti-hypertensive regimens are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.2
Change of serum potassium
This study will gain insight into the effect of spironolactone treatment on serum potassium. The concentrations of serum potassium (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum potassium are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.3
Change of plasma aldosterone
This study will gain insight into the effect of spironolactone treatment on plasma aldosterone. The concentrations of plasma aldosterone (ng/dL) are measured before and after spironolactone treatment, respectively. The changes of plasma aldosterone are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.4
Change of plasma renin
This study will gain insight into the effect of spironolactone treatment on plasma renin. The concentrations of plasma renin (mU/L) are measured before and after spironolactone treatment, respectively. The changes of plasma renin are analyzed after the spironolactone treatment.
Time frame
From enrollment to spironolactone treatment at 12 months.Sponsors and contacts
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Source ClinicalTrials.gov