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

NCT06938516 | Recruiting DMC

• 1 other identifier: AMAP/22/NebHyp/001
• Study Type: observational
• Target: 4,537
• Locations: 7 countries
• Sites: 49

Brief 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.

Conditions

Hypertension

Keywords

High Blood Pressure; Nebivolol in high blood pressure; Use of Nebilet in high blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in mean sitting systolic blood pressure from baseline to one year of treatment in hypertensive patients on Nebilet based treatment.

  Blood pressure of the study patients will be recorded and documented within a time period of every 3 months since baseline visit.

  Baseline to 12 months

Secondary Outcomes (10)

• To assess the impact of Nebilet based treatment in changing diastolic BP (DBP) in hypertensive patients in real-world setting from baseline to one year of treatment.

  Baseline to 12 months

• Change in mean sitting SBP and DBP from baseline to two years and at the end of three years in hypertensive patients on Nebilet based treatment.

  Baseline to 24 months and 36 months

• To evaluate the proportions of patients achieving target BP goal (<140/90 mm Hg) at different time points (12 months, 24 months, and 36 months of treatment) with Nebilet based as combination treatment.

  12, 24 and 36 months

• To assess the association of various risk factors (diabetes, obesity, and hypercholesterolemia) on development of major cardiac events in patients who achieve BP control over a period of 36 months.

  36 months

• To study the prescription patterns of Nebilet®-based treatment in terms of frequency per day in real-world settings.

  36 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from South-East Asia countries will be enrolled. The names of the participating countries are as follows: 1. Taiwan 2. Indonesia 3. South Korea 4. Philippines 5. Thailand 6. Malaysia 7. Vietnam

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.Menarini Asia-Pacific Holdings Pte Ltd: lead

Study Sites (49)

Telogorejo Hospital

Semarang, Central Java, 50134, Indonesia

RECRUITING

Bethesda Hospital

Yogyakarta, Central Java, 55223, Indonesia

RECRUITING

Panti rapih Hospital

Yogyakarta, Central Java, 55223, Indonesia

RECRUITING

Husada Utama Hospital

Surabaya, East Java, 60131, Indonesia

RECRUITING

Premere Surabaya Hospital

Surabaya, East Java, 60131, Indonesia

RECRUITING

National Cardiovascular Center Harapan Kita Hospital

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

RECRUITING

Metropolitan Medical Centre Hospital

Jakarta, Jakarta Special Capital Region, 12940, Indonesia

RECRUITING

Bidakara Medical Centre

Selatan, Jakarta Special Capital Region, 12870, Indonesia

RECRUITING

PT Ekamas International Hospital

Pekanbaru, Riau, 28282, Indonesia

RECRUITING

Stella Maris Hospital

Makassar, South Sulawasi, 90111, Indonesia

RECRUITING

Bukit Asam Medika Hospital

Palembang, South Sumatra, 31716, Indonesia

RECRUITING

Advent Hospital

Bandung, West Java, 40131, Indonesia

RECRUITING

Borromeus Hospital

Bandung, West Java, 40131, Indonesia

RECRUITING

RSUD Syamsudin Hospital

Sukabumi, West Java, 43113, Indonesia

RECRUITING

Semen Padang Hospital

Padang, West Sumatra, 25161, Indonesia

RECRUITING

DrThong,Leow,Chiam & Partners

Kuala Lumpur, Kuala Lumpur, 50250, Malaysia

RECRUITING

Klinik Pembangunan Sdn. Bhd

Kuala Lumpur, Kuala Lumpur, 50490, Malaysia

RECRUITING

Pantai HKL

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Columbia Asia Hospital Seremban

Seremban, Negeri Sembilan, 70300, Malaysia

RECRUITING

Mawar Medical Centre

Seremban, Negeri Sembilan, 70300, Malaysia

ACTIVE NOT RECRUITING

Bukit Tinggi Medical Centre

Klang, Selangor, 41200, Malaysia

RECRUITING

Mary Mediatrix Medical Center

Lipa, Batangas, 4217, Philippines

RECRUITING

Veterans Memorial Medical Center

Quezon City, Manila, 1110, Philippines

RECRUITING

Kangbuk Samsung Hospital

Seoul, Jongno District Seoul, 03181, South Korea

RECRUITING

Eunpyeong St. Mary's Hospital

Seoul, Seoul, 03312, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Far Eastern Memorial Hospital (FEMH)

New Taipei City, Banqiao, 220, Taiwan

RECRUITING

Changhua Christian Hospital (CCH)

Changhua, Changhua County, 500, Taiwan

RECRUITING

Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY)

Pozi, Chiayi County, 613, Taiwan

NOT YET RECRUITING

Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK)

Taoyuan District, Guishan District, 333, Taiwan

ACTIVE NOT RECRUITING

Hualien Tzu-Chi Hospital (HTCH)

Hualien City, Hualien County, 970, Taiwan

RECRUITING

Asia University Hospital (AUH)

Taipei, Nangang Dist., 115, Taiwan

RECRUITING

National Cheng Kung University Hospital (NCKUH)

Tainan, North District, 704, Taiwan

RECRUITING

Kaohsiung Medical University Hospital (KMUH)

Kaohsiung City, Sanmin District, 80756, Taiwan

RECRUITING

Taipei Medical University Hospital (TMUH)

Taipei, Xinyi District, 110, Taiwan

RECRUITING

Taichung Veterans General Hospital (TVGH)

Taichung, Xitun District, 407219, Taiwan

RECRUITING

Chi-Mei Medical Center (CMC)

Tainan, Yongkang Dist., 704, Taiwan

ACTIVE NOT RECRUITING

MacKay Memorial Hospital (MMH)

Taipei, Zhongshan District, 104, Taiwan

RECRUITING

National Taiwan University Hospital (NTUH)

Taipei, Zhongzheng District, 100, Taiwan

RECRUITING

Vajira Hospital Namindradhiraj University

Dusit, Bangkok, 10300, Thailand

RECRUITING

Wetchakarunrasm Hospital

Nong Chok, Bangkok, 10530, Thailand

RECRUITING

Burapha University

Chon Buri, Changwat Chon Buri, 20131, Thailand

RECRUITING

Central Chet Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

RECRUITING

Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

Anand Mahidhol Hospital

Lopburi, Lopaburi, 15000, Thailand

RECRUITING

CanTho General Hospital

Can Tho, Can Tho City, 900000, Vietnam

RECRUITING

Hanoi Heart Hospital

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Cho Ray Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

COMPLETED

Hue Central Hospital

Huế, Hue, 530000, Vietnam

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr Radhika Mehta

  A. Menarini Asia-Pacific Holding Pte Ltd

  STUDY DIRECTOR

Central Study Contacts

Dr Radhika Mehta

CONTACT

+65-93885069; radhika.mehta@menariniapac.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: December 20, 2023
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

TH (6); PH (2); MY (6); TW (13); VN (4); KR (3); ID (15)