Status:
UNKNOWN
Early Sequential Nephron Blockade in Acute Heart Failure Patients: A Randomised, Controlled Study
Lead Sponsor:
Chiang Mai University
Conditions:
Acute Heart Failure
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tre...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04465123
Start Date
August 13 2020
End Date
December 31 2022
Last Update
August 18 2020
Active Locations (1)
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1
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200