VITAL: Real-World Evaluation of Amlodipine/Valsartan. (VITAL)
Evaluation of Clinical Effectiveness in Real-World Clinical Practice, as Well as the Safety and Adherence to Therapy With a Fixed-Dose Combination of Amlodipine and Valsartan
The goal of this observational study is to evaluate the effectiveness, safety, and treatment adherence of a fixed-dose combination of amlodipine and valsartan in adults with grade 2-3 hypertension in real-world clinical practice in Kazakhstan. The study will include patients who have already been prescribed the fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine medical care, independently of their participation in the study.
The main questions it aims to answer are:
What proportion of participants achieve the target blood pressure after 12 weeks of treatment with the fixed-dose combination of amlodipine and valsartan? How well do participants adhere to treatment, and what patient characteristics are associated with treatment adherence? What changes occur in blood pressure, heart rate, quality of life, and selected laboratory measures during the 12-week observation period? What adverse events occur during treatment?
Participants will:
Have their clinical and demographic information and data from routine medical care recorded during the study.
Have blood pressure, heart rate, and other relevant clinical data assessed during the 12-week observation period.
Complete questionnaires assessing treatment adherence and quality of life. Participate in follow-up visits at 4, 8, and 12 weeks; the 4- and 8-week visits will be conducted remotely, while the enrollment and 12-week visits will be conducted at the study site.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Aktobe、カザフスタン
- 'Kuanysh' LLP Health Centre
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Aktobe、カザフスタン
- 'Phoenix Hospital' LLP
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Aktobe、カザフスタン
- Sara Clinic Medical Centre LLP
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Almaty、カザフスタン
- "Medical Assistance Group" LLP
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Almaty、カザフスタン
- 'Vector Vita' Medical Centre LLP
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Almaty、カザフスタン
- State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
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Astana、カザフスタン
- "Green Clinic" LLP
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Astana、カザフスタン
- "Kazakhstan Social and Medical Company 'ZHANYA' LLP"
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Astana、カザフスタン
- State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
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Shymkent、カザフスタン
- "Clinic DL-ECO" LLP
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Shymkent、カザフスタン
- "Esculap-Vita" LLP
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Shymkent、カザフスタン
- "OrkenMed" LLP
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Shymkent、カザフスタン
- 'Ai-Nury' Medical Centre LLP
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Ust-Kamenogorsk、カザフスタン
- 'GaMMA' Clinical and Diagnostic Centre LLP
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Ust-Kamenogorsk、カザフスタン
- State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital
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Ust-Kamenogorsk、カザフスタン
- The 'Outpatient Centre' organisation
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Turkistan Oblast
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Shymkent、Turkistan Oblast、カザフスタン
- "Medical Center Shubarsu" LLP
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Turkestan、Turkistan Oblast、カザフスタン
- "Clinic of Doctor Irsaliev N.R." LLP
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population will consist of adult male and female patients aged ≥18 years with a confirmed diagnosis of grade 2-3 hypertension who have been prescribed a fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of standard clinical practice, independently of participation in the study. The study will include patients with a medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs. A total of 216 participants will be enrolled and observed for up to 12 weeks.
説明
Inclusion Criteria:
- Male or female participants aged ≥18 years at the time of enrollment.
- Signed and dated written informed consent in accordance with ICH GCP and applicable local legislation before enrollment in the study.
- Women of childbearing potential must use an adequate method of contraception throughout the study.
- Documented diagnosis of grade 2-3 hypertension according to current clinical guidelines for hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg measured at two different visits.
- Treatment with a fixed-dose combination of amlodipine and valsartan (Agvistat®) prescribed by the treating physician as part of standard clinical practice before enrollment, independently of participation in this study.
- Medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs.
Exclusion Criteria:
- Participation in any randomized controlled trial within 3 months before enrollment in this study or during participation in this study.
- Atrial fibrillation; severe chronic heart failure (NYHA functional class III-IV or left ventricular ejection fraction ≤40% by echocardiography); or acute coronary syndrome or acute cerebrovascular event within the previous year.
- Secondary hypertension.
- Contraindications or conditions requiring caution listed in the prescribing information for the fixed-dose combination of amlodipine and valsartan, including: hypersensitivity to the active substances, other dihydropyridine derivatives, or any excipients; severe hepatic impairment, biliary cirrhosis, or cholestasis; concomitant use of aliskiren-containing medicinal products in patients with diabetes mellitus or renal impairment (eGFR <60 mL/min/1.73 m²); second or third trimester of pregnancy; severe hypotension; shock, including cardiogenic shock; left ventricular outflow tract obstruction, including hypertrophic obstructive cardiomyopathy or severe aortic stenosis; and hemodynamically unstable heart failure following acute myocardial infarction.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Amlodipine/valsartan-treated cohort
Adults with grade 2-3 hypertension who have been prescribed a fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine clinical practice, independently of participation in the study. Participants are observed for up to 12 weeks to assess treatment effectiveness, adherence, safety, blood pressure control, and quality of life. |
Fixed-dose combination of amlodipine and valsartan administered as part of routine clinical practice. The treatment is prescribed by the treating physician independently of study participation. The study does not assign treatment or provide the study drug. The available doses are amlodipine 5 mg/valsartan 160 mg and amlodipine 10 mg/valsartan 160 mg, administered once daily. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants achieving target blood pressure at 12 weeks
時間枠：12 weeks
|
Proportion of participants who achieve the target blood pressure after 12 weeks of therapy: <140/90 mmHg for the general population or <130/80 mmHg for participants at high cardiovascular risk and participants younger than 60 years. |
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association between treatment adherence and clinical and demographic characteristics
時間枠：12 weeks
|
Association between treatment adherence, assessed using the Morisky-Green scale, and clinical and demographic characteristics of participants, including age, sex, comorbidities, and duration of hypertension. |
12 weeks
|
|
Change in heart rate from baseline
時間枠：12 weeks
|
Change in heart rate from baseline during the observation period. |
12 weeks
|
|
Change in alanine aminotransferase (ALT) from baseline
時間枠：12 weeks
|
Change in alanine aminotransferase (ALT) level from baseline during the observation period. |
12 weeks
|
|
Change in aspartate aminotransferase (AST) from baseline
時間枠：12 weeks
|
Change in aspartate aminotransferase (AST) level from baseline during the observation period. |
12 weeks
|
|
Change in serum creatinine from baseline
時間枠：12 weeks
|
Change in serum creatinine level from baseline during the observation period. |
12 weeks
|
|
Change in blood glucose from baseline
時間枠：12 weeks
|
Change in blood glucose level from baseline during the observation period. |
12 weeks
|
|
Change in low-density lipoprotein cholesterol from baseline
時間枠：12 weeks
|
Change in low-density lipoprotein cholesterol (LDL-C) level from baseline during the observation period. |
12 weeks
|
|
Change in body mass index from baseline
時間枠：12 weeks
|
Change in body mass index (BMI) from baseline during the observation period. |
12 weeks
|
|
Change in EQ-5D quality of life score
時間枠：12 weeks
|
Change in the score of the standardized EQ-5D quality of life questionnaire during the observation period. |
12 weeks
|
|
Association of clinical and demographic factors with achievement of target blood pressure
時間枠：12 weeks
|
Association of clinical and demographic factors, including diabetes mellitus, obesity, grade of hypertension, chronic heart failure, age, and sex, with achievement of target blood pressure at 12 weeks of therapy. |
12 weeks
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|
Patient satisfaction with treatment
時間枠：12 week
|
Assessment of participants' satisfaction with treatment using a 5-point Likert scale. |
12 week
|
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Frequency and characteristics of adverse drug reactions
時間枠：12 weeks
|
Frequency and characteristics of adverse drug reactions associated with the use of the fixed-dose combination of amlodipine and valsartan, identified based on the analysis of adverse reaction reports (Yellow Cards). |
12 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- VP-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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