BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure

NCT07470554 | Active Not Recruiting

• 2 other identifiers: BIOTOOL-CHF DISCO101095653
• Study Type: observational
• Target: 4,254
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG. The availability of this comprehensive dataset of patients with severe HFrEF, prospectively and consistently collected, with the possibility to access a biobank to re-assay samples with novel biomarkers, provides a unique opportunity to derive preliminary data about the interaction between biomarkers of congestion and diuretic doses, that were prescribed based on clinical judgement, and therefore derive a machine learning-based algorithm than could be tested to guide the management of diuretic therapy

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF); Congestive Heart Failure(CHF)

Keywords

Biomarkers; Score; Congestion

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study will be time to death or first-hospitalisation for HF in the nine months after study entry

  9 month

Secondary Outcomes (1)

• - Variability in the congestion score assessed from baseline to Month 9 - Variability in the Kansas City Cardiomyopathy Questionnaire from baseline to month 9

  9 months

Study Arms (2)

Index cohort

Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients with congestive HF previously enrolled in the BIOSTAT-CHF cohorts. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months \[interquartile range (IQR) 15 - 27 months\]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom

You may qualify if:

• In order to have been included to participate in the index trial, a subject must have met all of the following criteria:
• age \>=18 years with symptoms of new-onset or worsening heart failure;
• objective evidence of cardiac dysfunction documented either by left ventricular ejection fraction \<=40% or plasma concentrations of brain natriuretic peptide (BNP) \>400 pg/mL and/or NT-proBNP \>2000 pg/mL;
• age \>=18 years;
• diagnosis of heart failure with a previous documented admission requiring diuretic treatment;
• treatment with furosemide \>=20 mg/day or equivalent;
• not previously treated or receiving \<=50% of target doses of ACE inhibitors or ARBs and/or beta-blockers;
• anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers. In both trials, patients could be enrolled as inpatients or from outpatient clinics.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• \- known diagnosis of septicaemia, known diagnosis of acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy, heart transplant recipient or admitted for cardiac transplantation or left ventricular assist device surgery, anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and-or cardiac resynchronization therapy, within 4 weeks, current known inability to follow instructions or comply with follow-up procedures, and treatment with medications or devices not approved in Europe.
• Patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, could be included when the primary diagnosis for admission to hospital or outpatient clinic visit was heart failure, rather than the concomitant condition

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (1)

• Voors AA, Anker SD, Cleland JG, Dickstein K, Filippatos G, van der Harst P, Hillege HL, Lang CC, Ter Maaten JM, Ng L, Ponikowski P, Samani NJ, van Veldhuisen DJ, Zannad F, Zwinderman AH, Metra M. A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure: rationale, design, and baseline characteristics of BIOSTAT-CHF. Eur J Heart Fail. 2016 Jun;18(6):716-26. doi: 10.1002/ejhf.531. Epub 2016 Apr 29.

  PMID: 27126231 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: December 10, 2024
• Primary Completion: February 20, 2025
• Study Completion (Estimated): January 10, 2034
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)