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

NCT04465123 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-08-18

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Kajohnsak Noppakun, MD · Instructor, Division of Nephrology, Department of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2022-07-31
Completion
2022-12-31

Countries

  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465123 on ClinicalTrials.gov