Early Sequential Nephron Blockade in Acute Heart Failure Patients: A Randomised, Controlled Study

Acute Kidney Injury Clinical Trial

— NEB-HF  

Official title:

Furosemide With Early Sequential Nephron Blockade Versus Furosemide Alone in Acute Heart Failure Patients With Furosemide-guided Diuretic Resistance: A Double-blinded, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465123
• Other study ID #: MED-2563-07080 (2)
• Status: Recruiting
• Phase: Phase 3
• Start date: August 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Chiang Mai University
• Contact: Kajohnsak Noppakun, MD
• Phone: +66815953465
• Email: kajohnsak.noppakun[@]cmu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate the efficacy of sequential nephron blockade by adding hydrochlorothiazide or spironolactone on intravenous furosemide compared to intravenous furosemide alone in the treatments of volume overload in patients with acute heart failure who have diuretic resistance from furosemide stress test.

Description:

This study is a randomised, double-blinded, double-dummy, placebo-controlled study to demonstrate the efficacy of oral hydrochlorothiazide or spironolactone in combination with intravenous furosemide compared to intravenous furosemide in combination with placebo. Dosage of intravenous furosemide will be adjusted according to pre-defined protocol. The primary outcome is urine volume during 72 hours after randomisation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Diagnosis of acute heart failure which is defined by 2 of the 3 following features:

=2+ leg edema, jugular venous pressure >10 cm from physical examination or central venous pressure >10 mmHg, and bilateral pulmonary edema or bilateral pleural effusion from chest radiography

• Patients consent to participate into the study

Exclusion Criteria:

• Patients who receive furosemide =500 mg/day or hydrochlorothiazide =100 mg/day or spironolactone =100 mg/day or tolvaptan of any doses

• Patients who have systolic blood pressure <100 mmHg or who need vasoactive drugs inotropic agents (except dobutamine)

• Patients with intravascular volume depletion from clinical evaluation

• Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate <15 ml/min/1.73 m2) or patients who receive maintenance dialysis

• Patients who require renal replacement therapy at the time of admission

• Patients whom diagnosed hypertrophic obstructive cardiomyopathy, severe valvular stenosis or complex congenital heart disease

• Patients with sepsis or systemic infection

• Pregnant women

• Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy

Related Conditions & MeSH terms

• Acute Heart Failure
• Acute Kidney Injury
• Heart Failure

Intervention

Drug:
• Spironolactone or hydrochlorothiazide
Patients will be received spironolactone or hydrochlorothiazide in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels =4 mEq/L, patients will be received spironolactone 100 mg every 12 hour for 72 hours. If serum potassium levels >4 mEq/L, patients will be received hydrochlorothiazide 50 mg every 12 hour for 72 hours.
• Placebo
Patients will be received spironolactone placebo or hydrochlorothiazide placebo in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels =4 mEq/L, patients will be received spironolactone placebo every 12 hour for 72 hours. If serum potassium levels >4 mEq/L, patients will be received hydrochlorothiazide placebo every 12 hour for 72 hours.

Locations

Country	Name	City	State
Thailand	Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine volume	Total urine volume after randomisation	72 hours
Secondary	Urine volume	Total urine volume after randomization	24 and 48 hours
Secondary	Body weight	Changes of patient's body weight	72 hours after randomisation
Secondary	Length of hospital admission	Number of days that patients need to stay in the hospital	During hospital admission period
Secondary	Furosemide dose	Total dosage of intravenous furosemide	72 hours after randomisation
Secondary	Levels of B-type atrial natriuretic peptide (BNP)	levels of pro-BNP	72 hours and 7 days after randomisation
Secondary	Number of participants with adverse events	All adverse events during hospital admission	During hospital admission
Secondary	Dyspnea score assessed by visual analogue scale	The scale is between 0 and 100. The higher scale represents lower level of dyspnea	At randomization, and 6, 12, 24, 48 and 72 hours after randomization