BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
By the re-analysis, in the BIOTOOL-CHF DISCO study, of a previously enrolled cohort of patients, a Biological Congestion Score (BCS) was newly developed. The BCS integrates four congestion-related biomarkers with key clinical variables.
The BIOTOOL-CHF VALID trial is designed to prospectively evaluate whether a BCS-assisted strategy for diuretic management improves clinical outcomes and quality of life in patients with chronic HF compared with standard care.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Luciano Potena
- Telefonní číslo: (+39) 0512143725
- E-mail: luciano.potena2@unibo.it
Studijní místa
-
-
Bologna
-
Bologna, Bologna, Itálie, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
- BNP> 400 pg/ml or 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 (CABG or PCI)/ 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) LVAD/ biventricular assist device (Bi-VAD) or heart transplantation;
- Severe stenotic valvular disease;
- GFR <15 ml/min (estimated by 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Zásahová skupina
|
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 eCRF. Final decisions and eventual therapy adjustments will remain at the discretion of the caring physicians. |
|
Žádný zásah: Kontrolní skupina
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to All-Cause Death
Časové okno: 3 months
|
Time from randomization to death from any cause.
Unit of Measure: Days
|
3 months
|
|
Number of Heart Failure Events per Participant
Časové okno: 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)
Časové okno: 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 Bio-Adrenomedullin (Bio-ADM) Plasma Concentration
Časové okno: 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
|
|
Percent Change from Baseline in Serum CA-125
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
Number of Participants Receiving All Recommended GDMT Classes
Časové okno: 3 months
|
Number of participants on all recommended GDMT classes at 3 months: all 4 pillars for HFrEF (RAAS inhibitor or ARNI, beta-blocker, MRA, SGLT2 inhibitor); SGLT2 inhibitor for HFmrEF/HFpEF. Unit of Measure: Number of Participants |
3 months
|
|
Number of Participants with Ventricular Arrhythmias Leading to ICD Intervention
Časové okno: 3 months
|
umber of participants with ventricular arrhythmias leading to ICD therapy, including anti-tachycardia pacing or shock, during the study period. Unit of Measure: Number of Participants |
3 months
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BIOTOOL-CHF VALID
- 101095653 (Jiné číslo grantu/financování: European Health and Digital Executive Agency)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .