Follows adults with high blood pressure who take Nebilet in everyday care
Follows adults with hypertension treated with Nebilet to see how well blood pressure is controlled.
Key facts
- Who runs it
- A.Menarini Asia-Pacific Holdings Pte Ltd
- Where
- Can Tho, Hanoi, Ho Chi Minh City, and Huế, VietnamSee the 4 sitesAlso in 6 other countries, 45 sites
- Trial code
- Registry title
- Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)
- Status
- Recruiting
- People taking part
- 4,537 people, planned
- Started
- 20 Dec 2023
- Expected to end
- Mar 2029
- Type of study
- Observational
- Record updated
- 22 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed or uncontrolled high blood pressure who are starting Nebilet-based treatment or have taken it for no more than 2 weeks.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed or uncontrolled high blood pressure (office SBP ≥140 and/or DBP ≥90 mmHg at screening). Heart-related conditions are allowed but not required.
- Earlier treatment
- Newly prescribed Nebilet-based treatment, or already on Nebilet-based treatment for no more than 2 weeks at screening.
Main reasons for not taking part
- A heart or blood vessel event less than 3 months ago
- Heart failure of NYHA Class IV
- Reasons that make Nebilet-based treatment unsafe, as listed in its product information
- Women of reproductive age who will not use adequate contraception
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV
- Patients with recent cardiovascular event within less than 3 months
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in Vietnam
Also in 6 other countries, 45 sites
- CanTho General HospitalCan Tho, VietnamContact: Dr. Trần Diệu HiềnTaking people
- Hanoi Heart HospitalHanoi, VietnamContact: Dr. Nguyen Sinh HienTaking people
- Cho Ray HospitalHo Chi Minh City, VietnamContact: Dr Radhika MehtaNo longer taking part
- Hue Central HospitalHuế, VietnamContact: Prof. Dr. Nguyen Ta DongTaking people
About the trial
What the trial wants to find out
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 designed to assess the effectiveness and safety of Nebilet® (nebivolol) in hypertensive patients. The study aims to evaluate changes in systolic and diastolic blood pressure from baseline to 12, 24, and 36 months, as well as treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes.
Read full original descriptionShow less
A total of approximately 5,000 hypertensive patients with or without cardiovascular comorbidities will be enrolled across seven Asian countries (Malaysia, Indonesia, the Philippines, Korea, Vietnam, Thailand, and Taiwan). Patients newly initiated on Nebilet®-based treatment or already receiving Nebilet® for no more than two weeks prior to screening will be eligible for inclusion.
Patients will be followed at regular intervals for up to three years. The study will also assess the correlation between home and office blood pressure measurements and compare Nebilet® monotherapy with combination therapy in achieving target blood pressure control. The findings from this study will provide real-world insights into the clinical management of hypertension with Nebilet® and its impact on patient outcomes.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study
- Plain-language title
- Follows adults with high blood pressure who take Nebilet in everyday careGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06938516, who can take part
- Record updated
- 22 April 2025