BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Luciano Potena
- Número de teléfono: (+39) 0512143725
- Correo electrónico: luciano.potena2@unibo.it
Ubicaciones de estudio
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Bologna
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Bologna, Bologna, Italia, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization
- Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms
At least one of the following:
- At discharge from hospitalization for heart failure
- History of hospitalization for heart failure in the previous 3 months
- History of treatment with intravenous diuretics or inotropes in ambulatory setting in the previous 3 months
- B-type Natriuretic Peptide (BNP) > 400 pg/ml or N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml if in sinus rhythm or BNP > 800 pg/ml or NT-proBNP > 2000 pg/ml if in atrial fibrillation (AF) assessed within 4 weeks before enrolment
Exclusion criteria:
- Acute coronary syndrome or cerebrovascular accident in the previous 30 days
- Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)
- Clinical congestion score greater or equal to 5 at the time of randomization
- Any cardiovascular intervention (cardiac surgery/coronary revascularization (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI))/ Cardiac Resynchronization Therapy (CRT) implant, percutaneous treatment of valve disease, arrhythmias ablation) performed in the previous 3 months or planned in the following 3 months
- Active myocarditis
- Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice
- Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation
- Severe stenotic valvular disease
- Glomerular Filtration Rate (GFR) <15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)
- Liver cirrhosis with ascites
- Significant cognitive impairment
- Pregnancy or planned pregnancy during the study period
- Active malignancy or severe hematological disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo de Intervención
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In patients randomized to the intervention arm, clinical variables and biomarker results will be entered into the score calculator.
The calculator will provide to the clinician an estimate of the degree of congestion by the BCS, and the probability of cardiovascular hospitalization or death within the subsequent 3 months.
Discrepancies will be recorded in the electronic Case Report Form (eCRF).
Final decisions and eventual therapy adjustments will remain at the discretion of the caring physicians.
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Sin intervención: Grupo de control
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Periodo de tiempo: 3 months
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Title: Win Ratio of Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and Change in KCCQ-TSS) at 3 Months Description: To compare BCS-guided management vs. standard of care in chronic heart failure. The hierarchical composite endpoint is assessed using the win ratio method, combining in priority order: (1) time to all-cause death (days), (2) number of heart failure events (HF hospitalizations, emergency visits, or unplanned parenteral HF therapy; count), and (3) change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS; range 0-100 points, higher scores indicate better health status). The three components are combined into a single win ratio value via the hierarchical win ratio method; no separate unit applies to each component independently. Unit of Measure: Win Ratio |
3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to All-Cause Death
Periodo de tiempo: 3 months
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Time from randomization to death from any cause.
Unit of Measure: Days
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3 months
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Number of Heart Failure Events per Participant
Periodo de tiempo: 3 months
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Number of heart failure events per participant, including HF hospitalizations, emergency department visits for heart failure, and unplanned parenteral HF therapy. Unit of Measure: Number of events |
3 months
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Change from Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Periodo de tiempo: Baseline and 3 months
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Change from baseline to 3 months in KCCQ-TSS. Scale range: 0 to 100 points; higher scores indicate better health status. Unit of Measure: Points |
Baseline and 3 months
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Percent Change from Baseline in Serum CA-125
Periodo de tiempo: Baseline and 3 months
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Percent change from baseline to 3 months in serum CA-125, measured in U/mL.
Unit of Measure: Percent change
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Baseline and 3 months
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Percent Change from Baseline in Serum NT-proBNP
Periodo de tiempo: Baseline and 3 months
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Percent change from baseline to 3 months in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP), measured in pg/mL. Unit of Measure: Percent change |
Baseline and 3 months
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Number of Participants with Dyskalemia
Periodo de tiempo: 3 months
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Number of participants with at least one occurrence of dyskalemia, defined as serum potassium below 3.5 mEq/L or above 5.0 mEq/L at any time point. Unit of Measure: Number of Participants |
3 months
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Number of Participants Receiving at Least 50% of Target GDMT Doses
Periodo de tiempo: 3 months
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Number of participants receiving at least 50% of the target dose for all prescribed Guideline-Directed Medical Therapy (GDMT) classes at 3 months. Unit of Measure: Number of Participants |
3 months
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Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration
Periodo de tiempo: Baseline and 3 months
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Percent change from baseline to 3 months in plasma Bio-Adrenomedullin (bio-ADM), measured in pmol/L.
Unit of Measure: Percent change
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Baseline and 3 months
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Number of Participants Receiving All Recommended GDMT Classes
Periodo de tiempo: 3 months
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Number of participants on all recommended Guideline-Directed Medical Therapy (GDMT) classes at 3 months: all 4 pillars for Heart Failure with Reduced Ejection Fraction (HFrEF) (Renin-Angiotensin-Aldosterone System (RAAS) inhibitor or Angiotensin Receptor-Neprilysin Inhibitor (ARNI), beta-blocker, Mineralocorticoid Receptor Antagonist (MRA), Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor); SGLT2 inhibitor for Heart Failure with Mildly Reduced Ejection Fraction (HFmrEF)/Heart Failure with Preserved Ejection Fraction (HFpEF). Unit of Measure: Number of Participants |
3 months
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Number of Participants with Ventricular Arrhythmia Leading to Implantable Cardioverter-Defibrillator (ICD) Intervention
Periodo de tiempo: 3 months
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Number of participants with ventricular arrhythmia leading to Implantable Cardioverter-Defibrillator (ICD) therapy, including anti-tachycardia pacing or shock, during the study period. Unit of Measure: Number of Participants |
3 months
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- BIOTOOL-CHF VALID
- 101095653 (Otro número de subvención/financiamiento: European Health and Digital Executive Agency)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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