BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
Przegląd badań
Status
Szczegółowy opis
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Luciano Potena
- Numer telefonu: (+39) 0512143725
- E-mail: luciano.potena2@unibo.it
Lokalizacje studiów
-
-
Bologna
-
Bologna, Bologna, Włochy, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Grupa Interwencyjna
|
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.
|
|
Brak interwencji: Grupa kontrolna
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Ramy czasowe: 3 months
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to All-Cause Death
Ramy czasowe: 3 months
|
Time from randomization to death from any cause.
Unit of Measure: Days
|
3 months
|
|
Number of Heart Failure Events per Participant
Ramy czasowe: 3 months
|
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
|
|
Change from Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Ramy czasowe: Baseline and 3 months
|
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
|
|
Percent Change from Baseline in Serum CA-125
Ramy czasowe: Baseline and 3 months
|
Percent change from baseline to 3 months in serum CA-125, measured in U/mL.
Unit of Measure: Percent change
|
Baseline and 3 months
|
|
Percent Change from Baseline in Serum NT-proBNP
Ramy czasowe: Baseline and 3 months
|
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
|
|
Number of Participants with Dyskalemia
Ramy czasowe: 3 months
|
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
|
|
Number of Participants Receiving at Least 50% of Target GDMT Doses
Ramy czasowe: 3 months
|
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
|
|
Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration
Ramy czasowe: Baseline and 3 months
|
Percent change from baseline to 3 months in plasma Bio-Adrenomedullin (bio-ADM), measured in pmol/L.
Unit of Measure: Percent change
|
Baseline and 3 months
|
|
Number of Participants Receiving All Recommended GDMT Classes
Ramy czasowe: 3 months
|
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
|
|
Number of Participants with Ventricular Arrhythmia Leading to Implantable Cardioverter-Defibrillator (ICD) Intervention
Ramy czasowe: 3 months
|
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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BIOTOOL-CHF VALID
- 101095653 (Inny numer grantu/finansowania: European Health and Digital Executive Agency)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .