A Study of Ultra High Dose Diuretics to Treat Heart Failure

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bumetanide

Furosemide

About this trial

This is an interventional treatment trial for Heart Failure; With Decompensation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultra-high dose diuretic group

Standard dose diuretic group

Arm Description

Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide.

Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide.

Outcomes

Primary Outcome Measures

Urine Output

The total volume of urine produced in liters (L) over 24 hours after initiation of intravenous diuretic.

Secondary Outcome Measures

Change in Body Weight

Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.

Change in NT-proBNP

Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.

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.

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 device at Baseline and 24 hours after initiation of intravenous diuretic.

Change in Iothalamate glomerular filtration rate (GFR)

Renal or kidney function was measured by GFR determined by iothalamate clearance. Iothalamate GFR will be measured at Baseline and 24 hours after initiation of intravenous diuretic.

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.

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.

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.

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.

Change in Left Atrial (LA) strain

LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

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.

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.

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').

Full Information

NCT ID

NCT06036914

First Posted

September 7, 2023

Last Updated

September 7, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT06036914

Brief Title

A Study of Ultra High Dose Diuretics to Treat Heart Failure

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure; With Decompensation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultra-high dose diuretic group

Arm Type

Experimental

Arm Description

Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide.

Arm Title

Standard dose diuretic group

Arm Type

Active Comparator

Arm Description

Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide.

Intervention Type

Drug

Intervention Name(s)

Bumetanide

Other Intervention Name(s)

Ultra-high dose diuretic

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Furosemide

Other Intervention Name(s)

Standard dose diuretic

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urine Output

Description

The total volume of urine produced in liters (L) over 24 hours after initiation of intravenous diuretic.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Change in Body Weight

Description

Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in NT-proBNP

Description

Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Urine Sodium Excretion

Description

Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in apnea-hypopnea index

Description

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 device at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Iothalamate glomerular filtration rate (GFR)

Description

Renal or kidney function was measured by GFR determined by iothalamate clearance. Iothalamate GFR will be measured at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Peripheral Vein Pressure

Description

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.

Time Frame

Baseline, 24 hours

Title

Change in Cardiac Output

Description

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.

Time Frame

Baseline, 24 hours

Title

Change in estimated Right Ventricular (RV) systolic pressure

Description

Estimated RV systolic pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Right Atrial (RA) pressure

Description

RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Left Atrial (LA) strain

Description

LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Left Ventricular (LV) global longitudinal strain

Description

LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in Right Ventricular (RV) global longitudinal strain

Description

RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

Time Frame

Baseline, 24 hours

Title

Change in E/e'

Description

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').

Time Frame

Baseline, 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Circulatory Failure Research Team

Phone

(507) 255-2200

First Name & Middle Initial & Last Name or Official Title & Degree

Yogesh Reddy, M.B.B.S

Phone

(507) 284-3687

Email

Reddy.Yogesh@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yogesh Reddy, M.B.B.S

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Circulatory Failure Research Team

Phone

507-255-2200

First Name & Middle Initial & Last Name & Degree

Yogesh Reddy, M.B.B.S

Phone

(507) 284-3687

Email

Reddy.Yogesh@mayo.edu

First Name & Middle Initial & Last Name & Degree

Yogesh Reddy, MBBS

First Name & Middle Initial & Last Name & Degree

Naveen Pereira, MD

12. IPD Sharing Statement

Plan to Share IPD

No

Links:

URL

http://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Heart Failure; With Decompensation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial