Status:
RECRUITING
Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)
Lead Sponsor:
A.Menarini Asia-Pacific Holdings Pte Ltd
Conditions:
Hypertension
Eligibility:
All Genders
18-100 years
Brief Summary
The HYIMPACT study (IMPACT of Nebilet® in Blood Pressure Control in Patients with Hypertension) is a multinational, multicenter, observational, prospective, longitudinal real-world evidence study desi...
Detailed Description
Introduction. Hypertension remains one of the leading risk factors for cardiovascular morbidity and mortality worldwide, contributing significantly to the burden of stroke, heart failure, and other ca...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years of age with either newly diagnosed or uncontrolled hypertension (office SBP ≥140 and/or DBP ≥90 mmHg recorded at the time of screening) as per ESC/ESH guidelines 2018.
- Hypertensive patients - with or without cardiovascular comorbidities (such as coronary artery disease, heart failure, peripheral artery disease, cerebrovascular disease, arrhythmias, and valvular heart disease) - who are newly prescribed or are already on Nebilet based treatment (no more than for 2 weeks at screening).
- Hypertensive patients willing to provide consent to participate in the study.
- Women of reproductive age who are willing to use adequate means of contraception.
Exclusion
- Patients with recent cardiovascular event within less than 3 months.
- Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV.
- Patients with contraindications to Nebilet based treatment as per respective Summary of Product Characteristic (SmPC) which in the treating physician's judgment may jeopardize the subject by his or her participation in this study or may hamper his or her ability to perform and complete procedures required in the study.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
4537 Patients enrolled
Trial Details
Trial ID
NCT06938516
Start Date
December 20 2023
End Date
March 1 2029
Last Update
April 22 2025
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Telogorejo Hospital
Semarang, Central Java, Indonesia, 50134
2
Bethesda Hospital
Yogyakarta, Central Java, Indonesia, 55223
3
Panti rapih Hospital
Yogyakarta, Central Java, Indonesia, 55223
4
Husada Utama Hospital
Surabaya, East Java, Indonesia, 60131