NCT07635810

Brief Summary

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 Heart Failure (HF) compared with standard care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2028

Last Updated

June 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

March 10, 2026

Last Update Submit

June 10, 2026

Conditions

Congestive Heart Failure(CHF)

Keywords

CongestionBiomarkersHeart failure

Outcome Measures

Primary Outcomes (1)

  • Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 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

Secondary Outcomes (10)

  • Time to All-Cause Death

    3 months

  • Number of Heart Failure Events per Participant

    3 months

  • Change from Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)

    Baseline and 3 months

  • Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration

    Baseline and 3 months

  • Percent Change from Baseline in Serum CA-125

    Baseline and 3 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL
Other: Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram

Control Group

NO INTERVENTION

Interventions

Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogramOTHER

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Central Study Contacts

Luciano Potena

CONTACT

(+39) 0512143725luciano.potena2@unibo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

June 9, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

September 6, 2027

Study Completion (Estimated)

December 4, 2028

Last Updated

June 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)