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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Luciano Potena
- Telefonnummer: (+39) 0512143725
- E-Mail: luciano.potena2@unibo.it
Studienorte
-
-
Bologna
-
Bologna, Bologna, Italien, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Interventionsgruppe
|
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. |
|
Kein Eingriff: Kontrollgruppe
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to All-Cause Death
Zeitfenster: 3 months
|
Time from randomization to death from any cause.
Unit of Measure: Days
|
3 months
|
|
Number of Heart Failure Events per Participant
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BIOTOOL-CHF VALID
- 101095653 (Andere Zuschuss-/Finanzierungsnummer: European Health and Digital Executive Agency)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .