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

Last updated: August 16, 2020
Sponsor: Chiang Mai University
Overall Status: Active - Recruiting

Phase

3

Condition

Kidney Disease

Congestive Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04465123
MED-2563-07080 (2)
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 centralvenous pressure >10 mmHg, and bilateral pulmonary edema or bilateral pleural effusionfrom chest radiography

  • Patients consent to participate into the study

Exclusion

Exclusion Criteria:

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

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

  • Patients with intravascular volume depletion from clinical evaluation

  • Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate <15ml/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 valvularstenosis or complex congenital heart disease

  • Patients with sepsis or systemic infection

  • Pregnant women

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

Study Design

Total Participants: 100
Study Start date:
August 13, 2020
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

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