Predicting the effect of blood pressure lowering medication using Multi-Omics, a biomarker profile based on blood and urine analyses

Phase 1

Recruiting

• Conditions: Primary (essential) hypertension; MedDRA version: 21.1Level: PTClassification code: 10015488Term: Essential hypertension Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-505239-10-00
• Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Age 18 up to and including 75 years at the time of inclusion, 24 hours systolic blood pressure 130-164 (corresponding with grade 1-2 hypertension), without the use of blood pressure lowering agents (at screening for patients without pre-treatment or after 4 week wash-out of antihypertensive medication for subjects using a single antihypertensive agent at screening), Indication for antihypertensive therapy according to the 2023 European Society of Hypertension Guidelines for the management of arterial hypertension, Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons: 1 year postmenopausal, surgically sterile, or willing to use an acceptable method of contraception throughout the trial (oral contraceptives, approved contraceptive implants, long-term injectable contraception, intrauterine devices, or tubal ligation are allowed.), Subject is not treated with antihypertensive drugs or is treated with a single antihypertensive drug

Exclusion Criteria

Treatment with 2 or more antihypertensive drugs < 3 months before inclusion. It is not allowed to stop medication for study purposes in subjects treated with 2 or more anti-hypertensive drugs, Current biliary tract obstruction, Pregnancy, Known diagnosis of secondary hypertension to an identifiable cause other than treated sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, uncontrolled hyper- or hypothyroidism and intracranial tumor), Life expectancy < 1 year, Known side effect or contra-indication to treatment with calcium channel blcokers, Known side effect or contra-indication to treatment with angiotensin II receptor blockers, Known side effect or contra-indication to treatment with thiazide diuretics, Arm circumference > 46 cm, Sodium level outside reference range at screening visit, Potassium level outside reference range at screening visit, History of severe valvular or structural heart disease (excluding left ventricular hypertrophy), Calcium level outside reference range at screening visit, eGFR < 50 ml/min/1,73m2, Use of VEGF inhibitors, calcineurin inhibitors, glucocorticosteroids, erythropoietin stimulation agents, daily use of NSAID’s, Use of MDMA, methamphetamine, cocaine, Use of glycyrrhetinic acid containing products , i.e. liquorice, specific herbal teas, <4 weeks before inclusion. (If patients are willing to stop the intake of glycyrrhetinic acid containing products for the duration of the trial, they can be rescreened after 4 weeks of stopping glycyrrhetinic acid containing products), Use of potassium containing supplements, Concurrent use of medication or a supplement with significant drug interaction with study medication. Special attention is warranted for amlodipine which is metabolized by Cyp3A4. Subjects using strong inhibitors or inducers of Cyp3A4 are excluded from participation in this trial. A list of strong inhibitors and inducers is provided in Addendum 1 of the protocol. For information on possible drug interactions we refer to the website of Lexi-Interact Online (Lexicomp® Drug Interactions - UpToDate (doctorabad.com): https://doctorabad.com/UpToDate/d/di.htm)., History of myocardial infarction, angina pectoris, History of atrial fibrillation, Use of loop diuretics, History of NYHA class III or IV heart failure or known reduced left ventricular function (ejection fraction (EF) <30%), History of cerebrovascular accident or transient ischemic attack, History of hypertensive crisis, History of liver failure, History of skin cancer, History of gout, Current hyperparathyroidism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified