Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Phase 4

Recruiting

• Conditions: Primary Hypertension
• Interventions: Drug: Amlodipine; Drug: Olmesartan; Drug: Hydrochlorothiazide; Drug: Amlodipine/Olmesartan

• Registration Number: NCT05917275
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-23
• Study Start: 2024-04-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 weeks of Amlodipine	Amlodipine	-
4 weeks of Olmesartan	Olmesartan	-
4 weeks of Hydrochlorothiazide	Hydrochlorothiazide	-
4 weeks of Amlodipine/Olmesartan	Amlodipine/Olmesartan	-

Primary Outcome Measures

Name	Time	Method
Predictive value of Multi-Omics profile for blood pressure	4 weeks after start treatment	Predictive value of a MOMICs profile to discriminate subjects with a decrease in 24-hour blood pressure below the median from subjects with a decrease in 24-hour blood pressure above the median for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).

Secondary Outcome Measures

Name	Time	Method
Correlation Multi-Omics profile and adverse effects	correlation between changes from baseline to 4 weeks after start treatment	Correlation between changes in individual biomarkers and adverse effects as documented using adverse effects questionnaire and SF-36
Predictive value of Multi-Omics profile for night-time blood pressure	4 weeks after start treatment	Predictive value of a MOMICs profile to discriminate subjects with a decrease in night-time blood pressure below the median from subjects with a decrease in 24-hour blood pressure above the median, for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands