Heart failure pump failure Heart failure
Conditions
Interventions
and Ur-Na evaluation thereafter are repeated 3x a day (approx. 7 am , 3 pm and 
11 pm) in the first 48 hours, and diuretics will be further increased if the 
response remains sub therapeutic, including addition of other types of 
be doubled - up to 250 mg furosemide. Bolus administration of loop diuretics 
The proposed intervention (treatment arm I) is shown in Figure 3. It is adapted 
from a recent working-group paper based on findings from several observational 
studies and has been designed in consensus of an expert panel of HF 
specialists. After initial assessment and diagnostics (preferable <
1 hour) the 
patient will be treated with a bolus of loop diuretics that can vary from a 
minimal dose of 40 mg to a maximum of 250 mg furosemide depending on whether 
the patient already uses diuretics or not and based on the eGFR, following the 
dosage conversion table in Figure 4. Combination therapy with acetazolamide for the first 3 days is allowed in both study arms as advised in the local acute heart failure protocol Two hours after the
patients where this doesn*t prove possible (patient refuses UBC or has a 
medical contra-indication) the patient will be instructed to empty his/her 
bladder (which will be verified by means of bladder-scan) before sample 
collection. In case of urinary incontinence or insufficient bladder emptying, a 
UBC is mandatory. If Ur-Na is below target of 100 mmol/L, the next bolus will 
diuretics (See 5.2 use of co-interventions). Once the patient has reached an 
adequate diu
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age > 18 years; • HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology; • Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF; • An elevated NT-proBNP >300pg/ml; • Requiring the need for iv diuretics;
Exclusion criteria
Exclusion criteria: • Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) < 10 mL/min/1.73 m2; • Patients included in other investigational studies regarding heart failure. • Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a hierarchical composite calculated using a win-ratio approach of: i) Mortality (all-cause) at 90 days after hospitalization; ii) HF events at 90 days after hospitalization including hospitalization (see definition at 8.1.2 in the study protocol) wherein a single event or hospitalization will be sufficient to reach the combined endpoint; iii) Delta in QoL measured using the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) from baseline to 90 days after hospitalization Herein, all patients from the intervention group will be compared to all patients in the usual care group (see statistical methods). The win-ratio will prioritize according to the order above, and for any two patients a patient will win when advantage is shown defined by the conditions in table 2 in the study protocol. Thus, prioritizing mortality over HF events and events over QoL. When there is no win in any of the endpoints, there is a tie. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Delta NT-proBNP from admission to discharge: assessed by ELISA-based blood evaluation (Roche Diagnostics), measured clinically and thus non-blinded on day of admission and at day of discharge (or day -1 to max -2); and 90-days. • Successful decongestion at day 3 (window 2 - 4) and discharge (% of patients); defined as a clinical congestion score of 2 or less (as detailed in figure 4); and NYHA I-II (if NYHA >2 but clinical congestion is limited, use additional diagnostics to define the nature of dyspnea and confirm adequate decongestion); • Delta clinical congestion score from admission to discharge (continuous); • Quality of Life: assessed by several domains of the KCCQ questionnaire at 90 days after hospitalization (delta from baseline, continuous and number (%) of patients with an increase of >=10 points). • Adverse events (safety): all-cause readmissions at 90-days, all-cause and CV mortality at 90-days, (symptomatic) hypotension, hypokalemia, urinary tract infection, phlebitis, atrial fibrillation, fall/trauma and decompensated HF; • All-cause mortality and HF readmissions at 14 days after initial admission; All-cause mortality and HF readmissions at 6 months after initial admission (as described in the electronic patient file, endpoint will not be assessed by the even adjudication committee);• Worsening renal failure; analyzed as a continuous variable delta creatinine/baseline creatinine (in groups of 10%) at discharge and at 90-days follow-up; and dichotomous defined as delta creatinine >50%; • Occurrence of the need for chronic dialysis at 90-days FU; Hospital length of stay (days until discharge or end of medial treatment); • Days alive outside the hospital (at 90-days FU); • Time to first HF hospitalization and number of HF hospitalizations • Number of outpatient visits in the first 90-days FU; • Number of worsening HF events at 90-days FU; i.e. a summation of i) a >2 times increase in or | — |
Countries
Netherlands
Contacts
Public ContactM Hoen
Zuyderland
Outcome results
None listed