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Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

NCT05917275 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

  • Primary Hypertension

Interventions

DRUG

Amlodipine

4 weeks of Amlodipine

DRUG

Olmesartan

4 weeks of Olmesartan

DRUG

Hydrochlorothiazide

4 weeks of Hydrochlorothiazide

DRUG

Amlodipine/Olmesartan

4 weeks of Amlodipine/Olmesartan

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Joost Rutten · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917275 on ClinicalTrials.gov