Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)
Recruiting · NCT06938516 · Observational (researchers observe without assigning treatment) · Lead sponsor: A.Menarini Asia-Pacific Holdings Pte Ltd
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
49 locations listed.
- Chonnam National University Hospital - Gwangju, South Korea
- Vajira Hospital Namindradhiraj University - Dusit, Bangkok, Thailand
- Wetchakarunrasm Hospital - Nong Chok, Bangkok, Thailand
- Far Eastern Memorial Hospital (FEMH) - New Taipei City, Banqiao, Taiwan
- Mary Mediatrix Medical Center - Lipa, Batangas, Philippines
- CanTho General Hospital - Can Tho, Can Tho City, Vietnam
- Telogorejo Hospital - Semarang, Central Java, Indonesia
- Bethesda Hospital - Yogyakarta, Central Java, Indonesia
- Panti rapih Hospital - Yogyakarta, Central Java, Indonesia
- Changhua Christian Hospital (CCH) - Changhua, Changhua County, Taiwan
- Burapha University - Chon Buri, Changwat Chon Buri, Thailand
- Anand Mahidhol Hospital - Lopburi, Changwat Lop Buri, Thailand
- Central Chet Institute - Nonthaburi, Changwat Nonthaburi, Thailand
- Chiang Mai University - Chiang Mai, Chiang Mai, Thailand
- Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY) - Pozi, Chiayi County, Taiwan
- Husada Utama Hospital - Surabaya, East Java, Indonesia
- Premere Surabaya Hospital - Surabaya, East Java, Indonesia
- Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK) - Taoyuan, Guishan District, Taiwan
- Hanoi Heart Hospital - Hanoi, Hanoi, Vietnam
- Cho Ray Hospital - Ho Chi Minh City, Ho Chi Minh, Vietnam
- Hualien Tzu-Chi Hospital (HTCH) - Hualien City, Hualien County, Taiwan
- Hue Central Hospital - Huế, Hue, Vietnam
- National Cardiovascular Center Harapan Kita Hospital - Jakarta, Jakarta Special Capital Region, Indonesia
- Metropolitan Medical Centre Hospital - Jakarta, Jakarta Special Capital Region, Indonesia
- Bidakara Medical Centre - Selatan, Jakarta Special Capital Region, Indonesia
- Kangbuk Samsung Hospital - Seoul, Jongno District Seoul, South Korea
- DrThong,Leow,Chiam & Partners - Kuala Lumpur, Kuala Lumpur, Malaysia
- Klinik Pembangunan Sdn. Bhd - Kuala Lumpur, Kuala Lumpur, Malaysia
- Pantai HKL - Kuala Lumpur, Kuala Lumpur, Malaysia
- Veterans Memorial Medical Center - Quezon City, Manila, Philippines
- Asia University Hospital (AUH) - Taipei, Nangang Dist., Taiwan
- Columbia Asia Hospital Seremban - Seremban, Negeri Sembilan, Malaysia
- Mawar Medical Centre - Seremban, Negeri Sembilan, Malaysia
- National Cheng Kung University Hospital (NCKUH) - Tainan, North District, Taiwan
- PT Ekamas International Hospital - Pekanbaru, Riau, Indonesia
- Kaohsiung Medical University Hospital (KMUH) - Kaohsiung City, Sanmin District, Taiwan
- Bukit Tinggi Medical Centre - Klang, Selangor, Malaysia
- Eunpyeong St. Mary's Hospital - Seoul, Seoul, South Korea
- Stella Maris Hospital - Makassar, South Sulawasi, Indonesia
- Bukit Asam Medika Hospital - Palembang, South Sumatra, Indonesia
- Advent Hospital - Bandung, West Java, Indonesia
- Borromeus Hospital - Bandung, West Java, Indonesia
- RSUD Syamsudin Hospital - Sukabumi, West Java, Indonesia
- Semen Padang Hospital - Padang, West Sumatra, Indonesia
- Taipei Medical University Hospital (TMUH) - Taipei, Xinyi District, Taiwan
- Taichung Veterans General Hospital (TVGH) - Taichung, Xitun District, Taiwan
- Chi-Mei Medical Center (CMC) - Tainan, Yongkang Dist., Taiwan
- MacKay Memorial Hospital (MMH) - Taipei, Zhongshan District, Taiwan
- National Taiwan University Hospital (NTUH) - Taipei, Zhongzheng District, Taiwan