Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917275
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-06-06
Brief Title:
Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HT-PREDICT
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 olmesartanamlodipine
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 olmesartanamlodipine
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 olmesartanamlodipine
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
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 olmesartanamlodipine
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 olmesartanamlodipine
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 olmesartanamlodipine
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505239-10-00 | OTHER | CTIS | None |