NCT06938516Toboroz
Prospective Observational Study On The Impact Of Nebilet In Blood Pressure Control In Hypertensive Patients (HYIMPACT)
IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 22. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 4537 (tervezett)
- Első benyújtás
- 2025. ápr. 4.
- Kezdés
- 2023. dec. 20.
- Elsődleges befejezés
- 2028. nov. 30.
- Fő szponzor
- A.Menarini Asia-Pacific Holdings Pte Ltd
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT06938516
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 4537
- 2023. dec. 20. és az elsődleges befejezés (2028. nov. 30.) között
- 49 helyszín, 7 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Patient with heart failure based on New York Heart Association (NYHA) Functional Classification- Class IV.
Egyéb
- Patients with recent cardiovascular event within less than 3 months.
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (49)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Borromeus Hospital | Bandung | Indonézia | Toboroz |
| Advent Hospital | Bandung | Indonézia | Toboroz |
| National Cardiovascular Center Harapan Kita Hospital | Jakarta | Indonézia | Toboroz |
| Metropolitan Medical Centre Hospital | Jakarta | Indonézia | Toboroz |
| Stella Maris Hospital | Makassar | Indonézia | Toboroz |
| Semen Padang Hospital | Padang | Indonézia | Toboroz |
| Bukit Asam Medika Hospital | Palembang | Indonézia | Toboroz |
| PT Ekamas International Hospital | Pekanbaru | Indonézia | Toboroz |
| Bidakara Medical Centre | Selatan | Indonézia | Toboroz |
| Telogorejo Hospital | Semarang | Indonézia | Toboroz |
| RSUD Syamsudin Hospital | Sukabumi | Indonézia | Toboroz |
| Husada Utama Hospital | Surabaya | Indonézia | Toboroz |
| Premere Surabaya Hospital | Surabaya | Indonézia | Toboroz |
| Bethesda Hospital | Yogyakarta | Indonézia | Toboroz |
| Panti rapih Hospital | Yogyakarta | Indonézia | Toboroz |
| Chonnam National University Hospital | Gwangju | Dél-Korea | Toboroz |
| Eunpyeong St. Mary's Hospital | Seoul | Dél-Korea | Toboroz |
| Kangbuk Samsung Hospital | Seoul | Dél-Korea | Toboroz |
| Bukit Tinggi Medical Centre | Klang | Malajzia | Toboroz |
| Klinik Pembangunan Sdn. Bhd | Kuala Lumpur | Malajzia | Toboroz |
| DrThong,Leow,Chiam & Partners | Kuala Lumpur | Malajzia | Toboroz |
| Pantai HKL | Kuala Lumpur | Malajzia | Toboroz |
| Columbia Asia Hospital Seremban | Seremban | Malajzia | Toboroz |
| Mawar Medical Centre | Seremban | Malajzia | Fut, nem toboroz |
| Mary Mediatrix Medical Center | Lipa | Fülöp-szigetek | Toboroz |
| Veterans Memorial Medical Center | Quezon City | Fülöp-szigetek | Toboroz |
| Chiang Mai University | Chiang Mai | Thaiföld | Toboroz |
| Burapha University | Chon Buri | Thaiföld | Toboroz |
| Vajira Hospital Namindradhiraj University | Dusit | Thaiföld | Toboroz |
| Anand Mahidhol Hospital | Lopburi | Thaiföld | Toboroz |
| Wetchakarunrasm Hospital | Nong Chok | Thaiföld | Toboroz |
| Central Chet Institute | Nonthaburi | Thaiföld | Toboroz |
| Changhua Christian Hospital (CCH) | Changhua | Tajvan | Toboroz |
| Hualien Tzu-Chi Hospital (HTCH) | Hualien City | Tajvan | Toboroz |
| Kaohsiung Medical University Hospital (KMUH) | Kaohsiung City | Tajvan | Toboroz |
| Far Eastern Memorial Hospital (FEMH) | New Taipei City | Tajvan | Toboroz |
| Chang Gung Memorial Hospital-Chiayi branch (CGMH-CY) | Pozi | Tajvan | Toborzás még nem indult |
| Taichung Veterans General Hospital (TVGH) | Taichung | Tajvan | Toboroz |
| Chi-Mei Medical Center (CMC) | Tainan | Tajvan | Fut, nem toboroz |
| National Cheng Kung University Hospital Nckuh | Tainan | Tajvan | Toboroz |
| Taipei Medical University Hospital (TMUH) | Taipei | Tajvan | Toboroz |
| Asia University Hospital (AUH) | Taipei | Tajvan | Toboroz |
| National Taiwan University Hospital NTUH | Taipei | Tajvan | Toboroz |
| MacKay Memorial Hospital (MMH) | Taipei | Tajvan | Toboroz |
| Chung Gung Memorial Hospital-Linkou Branch (CGMH-LK) | Taoyuan | Tajvan | Fut, nem toboroz |
| CanTho General Hospital | Can Tho | Vietnám | Toboroz |
| Hanoi Heart Hospital | Hanoi | Vietnám | Toboroz |
| Cho Ray Hospital | Ho Chi Minh City | Vietnám | Befejeződött |
| Hue Central Hospital | Huế | Vietnám | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.