Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01978132
Eligibility Criteria:
Inclusion Criteria patients with primary hyperaldosteronism:
* Age 18-75 years
* Confirmed primary hyperaldosteronism (aldosterone \>0.28 nmol/l after salt loading)
* Serum potassium ≥ 3.5 mmol/L (with or without potassium supplementation)
* Written informed consent
Inclusion Criteria patients with primary hypertension:
* Age 18-75 years
* Primary hypertension
* Baseline aldosterone \<0.30 nmol/l and aldosterone-renin-ratio\<0.09
* Serum potassium ≥ 3.5 mmol/L
* Written informed consent
Exclusion Criteria for both arms (patients with primary hyperaldosteronism and patients with primary hypertension:
* Smoking
* History of atherosclerotic disease (myocardial infarction (MI), stroke, or peripheral vascular disease)
* Not possible to change the antihypertensive medication into only diltiazem with or without hydralazine, according to the treating physician.
* Not possible to temporarily interrupt statin treatment, if the patient use statins, according to the treating physician.
* Severe renal dysfunction (MDRD \< 30 ml/min)
* Second/third degree AV-block on electrocardiography
* Cardiac failure
* Diabetes Mellitus
* Use of acetylsalicylic acid and NSAID's theophylline, and dipyridamole
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01978132
Study Brief:
Protocol Section:
NCT01978132