Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT05917275

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Led by Radboud University Medical Center · Updated on 2024-06-10

96

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 up to and including 75 years
  • 24-hour systolic blood pressure between 130 and 164 without blood pressure medication at screening or after 4-week washout if previously treated with a single antihypertensive drug
  • Indication for antihypertensive therapy according to 2023 European Society of Hypertension Guidelines
  • Currently not treated or treated with a single antihypertensive drug
  • Female patients must be non-lactating and not at risk of pregnancy due to being 1 year postmenopausal, surgically sterile, or using accepted contraception methods
Not Eligible

You will not qualify if you...

  • Treatment with two or more antihypertensive drugs within 3 months before inclusion
  • Known secondary hypertension causes except treated sleep apnea
  • Use of VEGF inhibitors, calcineurin inhibitors, glucocorticosteroids, erythropoietin stimulants, or daily NSAIDs
  • Use of MDMA, methamphetamine, or cocaine
  • Use of glycyrrhetinic acid containing products within 4 weeks before inclusion unless willing to stop for study duration
  • Use of potassium-containing supplements
  • Use of medications or supplements with major interactions with study drugs, especially strong Cyp3A4 inhibitors or inducers
  • History of myocardial infarction, angina, atrial fibrillation, severe valvular or structural heart disease (except left ventricular hypertrophy)
  • History of NYHA class III/IV heart failure or left ventricular ejection fraction under 30%
  • History of stroke or transient ischemic attack
  • History of hypertensive crisis
  • History of liver failure
  • History of skin cancer
  • History of gout
  • Current hyperparathyroidism or biliary tract obstruction
  • Pregnancy
  • Life expectancy less than 1 year
  • Known side effects or contraindications to calcium channel blockers, angiotensin II receptor blockers, or thiazide diuretics
  • Arm circumference greater than 46 cm
  • Sodium, potassium, or calcium levels outside normal range at screening
  • Estimated glomerular filtration rate under 50 ml/min/1.73m2
  • Use of loop diuretics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Radboudumc

Nijmegen, Netherlands

Actively Recruiting

Loading map...

Research Team

I

Internal Medicine Secretary

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here