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Recruiting Observational

Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)

NCT06938516 · tracked via the Priya Life Science South Korea tracker
Sponsor
A.Menarini Asia-Pacific Holdings Pte Ltd
Phase
Observational
Started
2023-12-20
Last updated
2025-04-22

Condition(s) studied

Hypertension

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in mean sitting systolic blood pressure from baseline to one year of treatment in hypertensive patients on Nebilet based treatment. — Baseline to 12 months
    Blood pressure of the study patients will be recorded and documented within a time period of every 3 months since baseline visit.

Trial sites (49)

FacilityCityRegionStatus
Telogorejo Hospital Semarang Central Java Recruiting
Bethesda Hospital Yogyakarta Central Java Recruiting
Panti rapih Hospital Yogyakarta Central Java Recruiting
Husada Utama Hospital Surabaya East Java Recruiting
Premere Surabaya Hospital Surabaya East Java Recruiting
National Cardiovascular Center Harapan Kita Hospital Jakarta Jakarta Special Capital Region Recruiting
Metropolitan Medical Centre Hospital Jakarta Jakarta Special Capital Region Recruiting
Bidakara Medical Centre Selatan Jakarta Special Capital Region Recruiting
PT Ekamas International Hospital Pekanbaru Riau Recruiting
Stella Maris Hospital Makassar South Sulawasi Recruiting
Bukit Asam Medika Hospital Palembang South Sumatra Recruiting
Advent Hospital Bandung West Java Recruiting
Borromeus Hospital Bandung West Java Recruiting
RSUD Syamsudin Hospital Sukabumi West Java Recruiting
Semen Padang Hospital Padang West Sumatra Recruiting
DrThong,Leow,Chiam & Partners Kuala Lumpur Kuala Lumpur Recruiting
Klinik Pembangunan Sdn. Bhd Kuala Lumpur Kuala Lumpur Recruiting
Pantai HKL Kuala Lumpur Kuala Lumpur Recruiting
Columbia Asia Hospital Seremban Seremban Negeri Sembilan Recruiting
Mawar Medical Centre Seremban Negeri Sembilan Active Not Recruiting
Bukit Tinggi Medical Centre Klang Selangor Recruiting
Mary Mediatrix Medical Center Lipa Batangas Recruiting
Veterans Memorial Medical Center Quezon City Manila Recruiting
Kangbuk Samsung Hospital Seoul Jongno District Seoul Recruiting
Eunpyeong St. Mary's Hospital Seoul Seoul Recruiting
Chonnam National University Hospital Gwangju South Korea Recruiting
Far Eastern Memorial Hospital (FEMH) New Taipei City Banqiao Recruiting
Changhua Christian Hospital (CCH) Changhua Changhua County Recruiting
Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY) Pozi Chiayi County Not Yet Recruiting
Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK) Taoyuan Guishan District Active Not Recruiting
Hualien Tzu-Chi Hospital (HTCH) Hualien City Hualien County Recruiting
Asia University Hospital (AUH) Taipei Nangang Dist. Recruiting
National Cheng Kung University Hospital (NCKUH) Tainan North District Recruiting
Kaohsiung Medical University Hospital (KMUH) Kaohsiung City Sanmin District Recruiting
Taipei Medical University Hospital (TMUH) Taipei Xinyi District Recruiting
Taichung Veterans General Hospital (TVGH) Taichung Xitun District Recruiting
Chi-Mei Medical Center (CMC) Tainan Yongkang Dist. Active Not Recruiting
MacKay Memorial Hospital (MMH) Taipei Zhongshan District Recruiting
National Taiwan University Hospital (NTUH) Taipei Zhongzheng District Recruiting
Vajira Hospital Namindradhiraj University Dusit Bangkok Recruiting

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06938516 on ClinicalTrials.gov ↗ ← All trials in South Korea