a FOCUSed Prospective Registry on Acute Decompensation of Heart Failure With Reduced Ejection Fraction- The FOCUS-ADHF Registry

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

Objectives: <!-- --> 1. To describe the acute therapeutic management and discharge prescriptions for heart failure medications, including doses, in a selected population with ADHF. 2. To evaluate clinical outcomes and NT-proBNP variation in relation to initial intravenous medications, particularly comparing the use versus non-use of vasodilators. 3. To identify the incidence and timing of a significant therapeutic response through serial evaluations of LUS and echo-derived parameters, and to examine their association with the initial intravenous medications prescribed. 4. To investigate the association between the criteria for therapeutic response and clinical outcomes in both short- and medium-term follow-up, with a focus on the relationship to the initially administered therapy.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients within 24h since admission for an acute decompensation of heart failure (ADHF)\* (both acute on chronic and de novo) defined as

∙ signs and symptoms of volume overload with necessity of iv diuretic treatment.

‣ and NT-proBNP (N-terminal pro-B-type natriuretic peptide) \>1500 pg/mL or a B-type natriuretic peptide level of \>500 ng/mL.

• AND ALL THE FOLLOWING echo entry criteria at admission:

⁃ A dilated left ventricle (defined as a indexed LVEDD ≥ 31 mm/sm and ≥ 32 mm/sm or a indexed LVEDVol ≥ 75 ml/sm and ≥ 62 ml/sm in men and women respectively) AND/OR at least moderate functional mitral regurgitation (FMR).

⁃ Reduced ejection fraction (\<40%)

⁃ Increased LV filling pressure (defined as II°-III° Diastolic dysfunction) AND increased pulmonary artery pressure (i.e. echo estimated systolic pulmonary artery pressure \[sPAP\] ≥ 40 mmhg and/or echo estimated mean pulmonary artery pressure \[mPAP\] ≥ 20 mmHg).

Locations
Other Locations
Belgium
division of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.
RECRUITING
Genk
Italy
Rivoli Hospital
RECRUITING
Rivoli
San Giovanni Bosco Hospital
RECRUITING
Turin
Santa Maria della Misericordia, Azienda sanitaria universitaria Friuli Centrale,
RECRUITING
Udine
Contact Information
Primary
Maurizio Bertaina, MD
maurizio.bertaina@gmail.com
+393464300039
Time Frame
Start Date: 2025-04-27
Estimated Completion Date: 2030-08
Participants
Target number of participants: 600
Treatments
vasodilator treated
patients treated with vasodilator therapy after admission for an ADHF episode
Not vasodilator treated
Patients not treated with vasodilator therapy after admission for an ADHF episode
Sponsors
Collaborators: Hospital of Rivoli, Ziekenhuis Oost-Limburg
Leads: ASL Città di Torino

This content was sourced from clinicaltrials.gov