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

Recruiting now

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT06938516

Run by

A.Menarini Asia-Pacific Holdings Pte Ltd

People needed

4537

Starts

2023-12-20

Expected to finish

2029-03-01

Last updated by the study team

2025-04-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hue Central Hospital — Huế, Hue, Vietnam (enrolling)
• Bethesda Hospital — Yogyakarta, Central Java, Indonesia (enrolling)
• Panti rapih Hospital — Yogyakarta, Central Java, Indonesia (enrolling)
• Husada Utama Hospital — Surabaya, East Java, Indonesia (enrolling)
• Premere Surabaya Hospital — Surabaya, East Java, Indonesia (enrolling)
• National Cardiovascular Center Harapan Kita Hospital — Jakarta, Jakarta Special Capital Region, Indonesia (enrolling)
• Metropolitan Medical Centre Hospital — Jakarta, Jakarta Special Capital Region, Indonesia (enrolling)
• Bidakara Medical Centre — Selatan, Jakarta Special Capital Region, Indonesia (enrolling)
• PT Ekamas International Hospital — Pekanbaru, Riau, Indonesia (enrolling)
• Stella Maris Hospital — Makassar, South Sulawasi, Indonesia (enrolling)
• Bukit Asam Medika Hospital — Palembang, South Sumatra, Indonesia (enrolling)
• Advent Hospital — Bandung, West Java, Indonesia (enrolling)
• Borromeus Hospital — Bandung, West Java, Indonesia (enrolling)
• RSUD Syamsudin Hospital — Sukabumi, West Java, Indonesia (enrolling)
• Semen Padang Hospital — Padang, West Sumatra, Indonesia (enrolling)
• DrThong,Leow,Chiam & Partners — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
• Klinik Pembangunan Sdn. Bhd — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
• Pantai HKL — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
• Columbia Asia Hospital Seremban — Seremban, Negeri Sembilan, Malaysia (enrolling)
• Central Chet Institute — Nonthaburi, Changwat Nonthaburi, Thailand (enrolling)
• Chiang Mai University — Chiang Mai, Chiang Mai, Thailand (enrolling)
• CanTho General Hospital — Can Tho, Can Tho City, Vietnam (enrolling)
• Hanoi Heart Hospital — Hanoi, Hanoi, Vietnam (enrolling)
• Telogorejo Hospital — Semarang, Central Java, Indonesia (enrolling)
• Bukit Tinggi Medical Centre — Klang, Selangor, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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