A Study of Ultra High Dose Diuretics to Treat Heart Failure

Heart Failure; With Decompensation Clinical Trial

Official title:

Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06036914
• Other study ID #: 23-005262
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 27, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of decompensated heart failure receiving intravenous diuretics
• Ability to provide informed consent

Exclusion Criteria:

• Patients on home inotrope medications
• Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis
• Patients lacking the capacity to consent for themselves
• Known pregnancy or breastfeeding mothers
• Complex congenital heart disease
• Allergy to furosemide or bumetanide
• Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support at the time of randomization
• Hypotension with systolic blood pressure <80 mm Hg at the time of randomization
• Acute coronary syndrome
• Sustained Ventricular tachycardia requiring treatment in the last 48 hours
• Patients weighing = 40 kg

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Drug:
• Bumetanide
Bumetanide will be administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
• Furosemide
Furosemide will be administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours. Furosemide equivalents will be considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study will be 40 mg IV two times a day (BID) and the maximum dose will be 100 mg IV BID.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Output	The total volume of urine produced in liters (L) over 24 hours after initiation of intravenous diuretic.	24 hours
Secondary	Change in Body Weight	Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in NT-proBNP	Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Urine Sodium Excretion	Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in apnea-hypopnea index	The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea; AHI will be measured using a Watch Pat or Nox device at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Iohexol glomerular filtration rate (GFR)	Renal or kidney function was measured by GFR determined by Iohexol clearance. Iohexol GFR will be measured at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Peripheral Vein Pressure	Peripheral vein pressure (mm Hg) will be recorded from existing IV lines through pressure transducer monitoring at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Cardiac Output	Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in estimated Right Ventricular (RV) systolic pressure	Estimated RV systolic pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Right Atrial (RA) pressure	RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Left Atrial (LA) strain	LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Left Ventricular (LV) global longitudinal strain	LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in Right Ventricular (RV) global longitudinal strain	RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.	Baseline, 24 hours
Secondary	Change in E/e'	E/e' will be assessed using echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic. It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e').	Baseline, 24 hours