IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study

Status: Recruiting
Location: See all (49) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Advent Hospital
RECRUITING
Bandung
Borromeus Hospital
RECRUITING
Bandung
Metropolitan Medical Centre Hospital
RECRUITING
Jakarta
National Cardiovascular Center Harapan Kita Hospital
RECRUITING
Jakarta
Stella Maris Hospital
RECRUITING
Makassar
Semen Padang Hospital
RECRUITING
Padang
Bukit Asam Medika Hospital
RECRUITING
Palembang
PT Ekamas International Hospital
RECRUITING
Pekanbaru
Bidakara Medical Centre
RECRUITING
Selatan
Telogorejo Hospital
RECRUITING
Semarang
RSUD Syamsudin Hospital
RECRUITING
Sukabumi
Husada Utama Hospital
RECRUITING
Surabaya
Premere Surabaya Hospital
RECRUITING
Surabaya
Bethesda Hospital
RECRUITING
Yogyakarta
Panti rapih Hospital
RECRUITING
Yogyakarta
Malaysia
Bukit Tinggi Medical Centre
RECRUITING
Klang
DrThong,Leow,Chiam & Partners
RECRUITING
Kuala Lumpur
Klinik Pembangunan Sdn. Bhd
RECRUITING
Kuala Lumpur
Pantai HKL
RECRUITING
Kuala Lumpur
Columbia Asia Hospital Seremban
RECRUITING
Seremban
Mawar Medical Centre
ACTIVE_NOT_RECRUITING
Seremban
Philippines
Mary Mediatrix Medical Center
RECRUITING
Lipa
Veterans Memorial Medical Center
RECRUITING
Quezon City
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Taiwan
Changhua Christian Hospital (CCH)
RECRUITING
Changhua
Hualien Tzu-Chi Hospital (HTCH)
RECRUITING
Hualien City
Kaohsiung Medical University Hospital (KMUH)
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital (FEMH)
RECRUITING
New Taipei City
Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY)
NOT_YET_RECRUITING
Pozi
Taichung Veterans General Hospital (TVGH)
RECRUITING
Taichung
Chi-Mei Medical Center (CMC)
ACTIVE_NOT_RECRUITING
Tainan City
National Cheng Kung University Hospital (NCKUH)
RECRUITING
Tainan City
Asia University Hospital (AUH)
RECRUITING
Taipei
MacKay Memorial Hospital (MMH)
RECRUITING
Taipei
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
Taipei Medical University Hospital (TMUH)
RECRUITING
Taipei
Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK)
ACTIVE_NOT_RECRUITING
Taoyuan District
Thailand
Chiang Mai University
RECRUITING
Chiang Mai
Burapha University
RECRUITING
Chon Buri
Vajira Hospital Namindradhiraj University
RECRUITING
Dusit
Anand Mahidhol Hospital
RECRUITING
Lopburi
Wetchakarunrasm Hospital
RECRUITING
Nong Chok
Central Chet Institute
RECRUITING
Nonthaburi
Viet Nam
CanTho General Hospital
RECRUITING
Can Tho
Hanoi Heart Hospital
RECRUITING
Hanoi
Cho Ray Hospital
COMPLETED
Ho Chi Minh City
Hue Central Hospital
RECRUITING
Huế
Contact Information
Primary
Dr Radhika Mehta
radhika.mehta@menariniapac.com
+65-93885069
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2029-03
Participants
Target number of participants: 4537
Related Therapeutic Areas
Sponsors
Leads: A.Menarini Asia-Pacific Holdings Pte Ltd

This content was sourced from clinicaltrials.gov