NCT06938516Recruiting
Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)
IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4537 (estimated)
- First submitted
- 4 Apr 2025
- Start date
- 20 Dec 2023
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- A.Menarini Asia-Pacific Holdings Pte Ltd
- Diseases
- High blood pressure
- NCT number
- NCT06938516
What you commit to
- Study type: Observational
- Planned participants: 4537
- From 20 Dec 2023 to the primary completion date, 30 Nov 2028
- 49 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Borromeus Hospital Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
| Advent Hospital Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
| National Cardiovascular Center Harapan Kita Hospital Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Metropolitan Medical Centre Hospital Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Stella Maris Hospital Coordinator of this site? Confirm its status | Makassar | Indonesia | Recruiting |
| Semen Padang Hospital Coordinator of this site? Confirm its status | Padang | Indonesia | Recruiting |
| Bukit Asam Medika Hospital Coordinator of this site? Confirm its status | Palembang | Indonesia | Recruiting |
| PT Ekamas International Hospital Coordinator of this site? Confirm its status | Pekanbaru | Indonesia | Recruiting |
| Bidakara Medical Centre Coordinator of this site? Confirm its status | Selatan | Indonesia | Recruiting |
| Telogorejo Hospital Coordinator of this site? Confirm its status | Semarang | Indonesia | Recruiting |
| RSUD Syamsudin Hospital Coordinator of this site? Confirm its status | Sukabumi | Indonesia | Recruiting |
| Husada Utama Hospital Coordinator of this site? Confirm its status | Surabaya | Indonesia | Recruiting |
| Premere Surabaya Hospital Coordinator of this site? Confirm its status | Surabaya | Indonesia | Recruiting |
| Bethesda Hospital Coordinator of this site? Confirm its status | Yogyakarta | Indonesia | Recruiting |
| Panti rapih Hospital Coordinator of this site? Confirm its status | Yogyakarta | Indonesia | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Bukit Tinggi Medical Centre Coordinator of this site? Confirm its status | Klang | Malaysia | Recruiting |
| Klinik Pembangunan Sdn. Bhd Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| DrThong,Leow,Chiam & Partners Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Pantai HKL Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Columbia Asia Hospital Seremban Coordinator of this site? Confirm its status | Seremban | Malaysia | Recruiting |
| Mawar Medical Centre Coordinator of this site? Confirm its status | Seremban | Malaysia | Active, not recruiting |
| Mary Mediatrix Medical Center Coordinator of this site? Confirm its status | Lipa | Philippines | Recruiting |
| Veterans Memorial Medical Center Coordinator of this site? Confirm its status | Quezon City | Philippines | Recruiting |
| Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Recruiting |
| Burapha University Coordinator of this site? Confirm its status | Chon Buri | Thailand | Recruiting |
| Vajira Hospital Namindradhiraj University Coordinator of this site? Confirm its status | Dusit | Thailand | Recruiting |
| Anand Mahidhol Hospital Coordinator of this site? Confirm its status | Lopburi | Thailand | Recruiting |
| Wetchakarunrasm Hospital Coordinator of this site? Confirm its status | Nong Chok | Thailand | Recruiting |
| Central Chet Institute Coordinator of this site? Confirm its status | Nonthaburi | Thailand | Recruiting |
| Changhua Christian Hospital (CCH) Coordinator of this site? Confirm its status | Changhua | Taiwan | Recruiting |
| Hualien Tzu-Chi Hospital (HTCH) Coordinator of this site? Confirm its status | Hualien City | Taiwan | Recruiting |
| Kaohsiung Medical University Hospital (KMUH) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Far Eastern Memorial Hospital (FEMH) Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY) Coordinator of this site? Confirm its status | Pozi | Taiwan | Not yet recruiting |
| Taichung Veterans General Hospital (TVGH) Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Chi-Mei Medical Center (CMC) Coordinator of this site? Confirm its status | Tainan | Taiwan | Active, not recruiting |
| National Cheng Kung University Hospital Nckuh Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Medical University Hospital (TMUH) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Asia University Hospital (AUH) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital NTUH Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| MacKay Memorial Hospital (MMH) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Active, not recruiting |
| CanTho General Hospital Coordinator of this site? Confirm its status | Can Tho | Vietnam | Recruiting |
| Hanoi Heart Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Recruiting |
| Cho Ray Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Completed |
| Hue Central Hospital Coordinator of this site? Confirm its status | Huế | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.