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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Aktobe, Kazajstán
- 'Kuanysh' LLP Health Centre
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Aktobe, Kazajstán
- 'Phoenix Hospital' LLP
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Aktobe, Kazajstán
- Sara Clinic Medical Centre LLP
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Almaty, Kazajstán
- "Medical Assistance Group" LLP
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Almaty, Kazajstán
- 'Vector Vita' Medical Centre LLP
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Almaty, Kazajstán
- 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, Kazajstán
- "Green Clinic" LLP
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Astana, Kazajstán
- "Kazakhstan Social and Medical Company 'ZHANYA' LLP"
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Astana, Kazajstán
- State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
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Shymkent, Kazajstán
- "Clinic DL-ECO" LLP
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Shymkent, Kazajstán
- "Esculap-Vita" LLP
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Shymkent, Kazajstán
- "OrkenMed" LLP
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Shymkent, Kazajstán
- 'Ai-Nury' Medical Centre LLP
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Ust-Kamenogorsk, Kazajstán
- 'GaMMA' Clinical and Diagnostic Centre LLP
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Ust-Kamenogorsk, Kazajstán
- State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital
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Ust-Kamenogorsk, Kazajstán
- The 'Outpatient Centre' organisation
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Turkistan Oblast
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Shymkent, Turkistan Oblast, Kazajstán
- "Medical Center Shubarsu" LLP
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Turkestan, Turkistan Oblast, Kazajstán
- "Clinic of Doctor Irsaliev N.R." LLP
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of participants achieving target blood pressure at 12 weeks
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association between treatment adherence and clinical and demographic characteristics
Periodo de tiempo: 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
Periodo de tiempo: 12 weeks
|
Change in heart rate from baseline during the observation period. |
12 weeks
|
|
Change in alanine aminotransferase (ALT) from baseline
Periodo de tiempo: 12 weeks
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Change in alanine aminotransferase (ALT) level from baseline during the observation period. |
12 weeks
|
|
Change in aspartate aminotransferase (AST) from baseline
Periodo de tiempo: 12 weeks
|
Change in aspartate aminotransferase (AST) level from baseline during the observation period. |
12 weeks
|
|
Change in serum creatinine from baseline
Periodo de tiempo: 12 weeks
|
Change in serum creatinine level from baseline during the observation period. |
12 weeks
|
|
Change in blood glucose from baseline
Periodo de tiempo: 12 weeks
|
Change in blood glucose level from baseline during the observation period. |
12 weeks
|
|
Change in low-density lipoprotein cholesterol from baseline
Periodo de tiempo: 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
Periodo de tiempo: 12 weeks
|
Change in body mass index (BMI) from baseline during the observation period. |
12 weeks
|
|
Change in EQ-5D quality of life score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Patient satisfaction with treatment
Periodo de tiempo: 12 week
|
Assessment of participants' satisfaction with treatment using a 5-point Likert scale. |
12 week
|
|
Frequency and characteristics of adverse drug reactions
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Hipertensión
- Enfermedades cardiovasculares
- Aminoácidos, péptidos y proteínas
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Preparaciones farmacéuticas
- Azoles
- Aminoácidos
- Aminoácidos, esenciales
- Combinaciones de drogas
- Tetrazoles
- Dihidropiridinas
- Valina
- Aminoácidos, cadena ramificada
- Valsartán
- Amlodipino
- Combinación de medicamentos de amlodipina y valsartán
Otros números de identificación del estudio
- VP-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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