Active, not recruiting
Observational
BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure
Condition(s) studied
Heart Failure With Reduced Ejection Fraction (HFrEF)Congestive Heart Failure(CHF)
Study 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
Eligibility
Inclusion Criteria:
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;
* treatment with either oral or intravenous furosemide \>=40 mg/day or equivalent at the time of inclusion; not previously treated with evidence-based therapies (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers) or receiving \<=50% of target doses of these drugs at the time of inclusion; anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers by the treating physician.
For the validation cohort, patients had to fulfil the following inclusion criteria:
* 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.
Exclusion Criteria:
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
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna |
Bologna |
Emilia-Romagna |
|
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