Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-01-19
Brief Title:
SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Enhanced Diuresis and Natriuresis in Acute Decompensated Heart Failure Patients Treated With SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution A Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAPA-TONIC
Brief Summary:
The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 SGLT-2 inhibitor among patients admitted for acute exacerbation of heart failure in determining a significant increase in diuresis and natriuresis It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function
Detailed Description:
All enrolled patients will undergo a comprehensive physical examination post-randomization This examination will involve a meticulous assessment of congestive heart failure CHF indicators encompassing the measurement of bodyweight BW taken in the morning before breakfast supine and standing blood pressure BP average of 3 readings and heart rate HR Fasting blood samples will be collected daily throughout the hospital stay to ascertain serum laboratory parameters creatinine sodium potassium and N-terminal pro b-type natriuretic peptide until achieving a clinically stabilized condition Urine output will be measured daily also to detect creatinine sodium potassium urinary levels and glycosuria Additionally an electrocardiogram and echocardiogram to derive EF using the modified Simpson rule with 2 cross-sectional views 4- and 2-chamber apical views right atrium volume RA volume mlm2 left atrial volume LA volume mlm2 inferior vena cava diameter IVC diameter cm interventricular septum thickness at end-diastole IVSd cm right ventricular basal diameter at end-diastole RVD1 basal mm right ventricular mid diameter at end-diastole RVD2 mid mm right ventricular longitudinal diameter at end-diastole RVD3 long mm right ventricular outflow tract at proximal and distal RVOT prox and distal mm fractional area change FAC E wave dominant ms A wave dominant ms tricuspid valve EA wave ratio EATrV tissue Doppler echocardiography TDE ms eak velocity in early diastole of tricuspid annulus TDI ms tricuspid valve ea ratio TDI ms peak systolic velocity tricuspid annulus Pulsed TDI ms will be conducted prior to hospital discharge
Patients will be categorized into 4 groups the first group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions 100 mL twice daily along with severe water restriction 500 mL the second group will receive intravenous furosemide as a bolus twice daily and severe water restriction 500 mL without hypertonic saline solutions the third group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions 100 mL twice daily severe water restriction 500 mL and SGLT2 inhibitors Dapagliflozin the fourth group will receive intravenous furosemide as a bolus without hypertonic saline solutions twice daily severe water restriction 500 mL and SGLT2 inhibitors Dapagliflozin The groups will maintain a normal sodium intake 120 mmolday The daily furosemide dosage will be determined based on diuretic requirements urinary output BP readings and the severity of congestion signs and symptoms The hypertonic saline solutions dosage for each patient in groups 1 and 3 will be determined following these guidelines for serum Na values of 125 milliequivalentL the hypertonic saline solutions concentration will be 46 for serum Na values between 126 and 135 milliequivalentL the hypertonic saline solutions concentration will be 35 and for serum Na values of 135 milliequivalentL the hypertonic saline solutions concentration will range between 14 and 24 Throughout the study period patients diagnosed with Heart Failure with Reduced Ejection Fraction HFrEF will receive angiotensin converting enzyme inhibitors sartans angiotensin receptor-neprilysin inhibitors beta blockers and mineralocorticoid inhibitors The objective is to optimize heart failure therapy in alignment with the most recent European Society of Cardiology guidelines published in August 2023 Daily there will be meticulous monitoring of body weight in the morning before breakfast and 24-hour urinary volume measurements Serum and urinary laboratory parameters will be assessed daily until achieving a clinically stabilized condition defined as a shift in New York Heart Association functional class to at least second b and reaching the ideal body weight calculated via the Lorenz formula Upon attaining this clinically stabilized state intravenous administration of furosemide and hypertonic saline solutions will cease transitioning to oral furosemide administration while maintaining the unchanged optimal therapy post-discharge according to the standard protocol
Patients will be categorized into 4 groups the first group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions 100 mL twice daily along with severe water restriction 500 mL the second group will receive intravenous furosemide as a bolus twice daily and severe water restriction 500 mL without hypertonic saline solutions the third group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions 100 mL twice daily severe water restriction 500 mL and SGLT2 inhibitors Dapagliflozin the fourth group will receive intravenous furosemide as a bolus without hypertonic saline solutions twice daily severe water restriction 500 mL and SGLT2 inhibitors Dapagliflozin The groups will maintain a normal sodium intake 120 mmolday The daily furosemide dosage will be determined based on diuretic requirements urinary output BP readings and the severity of congestion signs and symptoms The hypertonic saline solutions dosage for each patient in groups 1 and 3 will be determined following these guidelines for serum Na values of 125 milliequivalentL the hypertonic saline solutions concentration will be 46 for serum Na values between 126 and 135 milliequivalentL the hypertonic saline solutions concentration will be 35 and for serum Na values of 135 milliequivalentL the hypertonic saline solutions concentration will range between 14 and 24 Throughout the study period patients diagnosed with Heart Failure with Reduced Ejection Fraction HFrEF will receive angiotensin converting enzyme inhibitors sartans angiotensin receptor-neprilysin inhibitors beta blockers and mineralocorticoid inhibitors The objective is to optimize heart failure therapy in alignment with the most recent European Society of Cardiology guidelines published in August 2023 Daily there will be meticulous monitoring of body weight in the morning before breakfast and 24-hour urinary volume measurements Serum and urinary laboratory parameters will be assessed daily until achieving a clinically stabilized condition defined as a shift in New York Heart Association functional class to at least second b and reaching the ideal body weight calculated via the Lorenz formula Upon attaining this clinically stabilized state intravenous administration of furosemide and hypertonic saline solutions will cease transitioning to oral furosemide administration while maintaining the unchanged optimal therapy post-discharge according to the standard protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None