Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. The main objectives are: * Primary objective: \- To identify MOMICs biomarkers that predict the response in 24-hour blood pressure to antihypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine) * Secondary objectives: * To identify a MOMICs biomarker that predict the response in night-time blood pressure to anti-hypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine) * To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide. * Exploratory objective: * To assess changes in MOMICs biomarkers induced by each drug Participants will undergo three 4-week treatment periods: * Each subject receives 3 out of 4 possible treatments (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine). * Before and after each treatment period OMICS measurements and an ABPM are performed. * At the end of each treatment period blood is sampled for drug level testing to assess adherence. * Electrolytes and kidney function are checked 5-7 days after start of each treatment period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18 up to and including 75 years

• 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

• Subject is not treated with antihypertensive drugs or is treated with a single antihypertensive drug.

• 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 (oral contraceptives, approved contraceptive implants, long-term injectable contraception, intrauterine devices, or tubal ligation are allowed.)

Locations
Other Locations
Netherlands
Radboudumc
RECRUITING
Nijmegen
Contact Information
Primary
Internal Medicine Secretary
secretariaatstaf.aig@radboudumc.nl
+31243618819
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2025-10
Participants
Target number of participants: 96
Treatments
Experimental: 4 weeks of Amlodipine
Experimental: 4 weeks of Olmesartan
Experimental: 4 weeks of Hydrochlorothiazide
Experimental: 4 weeks of Amlodipine/Olmesartan
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov