Status:
NOT_YET_RECRUITING
Point-of-Care Ultrasound in Chronic Heart Failure
Lead Sponsor:
Masaryk University
Collaborating Sponsors:
University Hospital Brno
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study aims to determine whether Point-of-Care Ultrasound (POCUS)-guided treatment is non-inferior to standard NT-proBNP-based care in ambulatory patients following hospitalization for heart failu...
Detailed Description
Although ultrasound machines are routinely available in ambulatory settings these days, assessing congestion with POCUS during regular visits is not yet established as a standard of care for HF patien...
Eligibility Criteria
Inclusion
- Patients after hospitalization for acute heart failure (AHF)
- Symptoms (shortness of breath, oedema, decreased exercise tolerance, increase in abdominal circumference)
- Clinical signs (jugular vein distention, hepatojugular reflux, third heart sound, wet lung crackles, pitting oedema) or signs of congestion on CT, X-ray or ultrasound
- NT-proBNP \>450 pg/mL \<55 years old, \>900 pg/mL 55-75 years old, \>1800 pg/mL \>75 years old
- Increase in oral diuretic therapy or need for IV diuretics
Exclusion
- pregnancy or lactation
- under 18 years of age,
- current AHF due to a transient cause (Takotsubo syndrome, neurogenic myocardial stunning, septic cardiomyopathy, cardiac tamponade, pulmonary embolism with acute cor pulmonale, thyrotoxicosis, bradycardia \<40/min)
- planned surgical treatment of the HF cause, CRT implantation or valvular repair ≤ 30 days ago, STEMI or coronary angiography with PCI or CABG ≤ 30 days ago, untreated AV block III. and II. degree type 2, planned or previous heart transplantation, myocarditis ≤ 6 months ago, complex congenital heart disease, cardiac amyloidosis, hypertrophic and restrictive cardiomyopathy, constrictive pericarditis
- BMI over 40 kg/m2, cognitive deficit with MMSE \<18 points, life expectancy \< 12 months, progressive oncological disease, chronic liver failure Child-Pugh C, chronic kidney disease with eGFR \<0.25 ml/s
- current participation in another study or relative of investigators
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06887179
Start Date
April 1 2025
End Date
December 31 2029
Last Update
March 25 2025
Active Locations (1)
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1
University Hospital Brno
Brno, Czechia, 625 00