Status:
COMPLETED
Effect of Diuretics Withdrawal in Chronic Heart Failure with Reduced Ejection Fraction
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Sociedad Andaluza de Cardiología
Conditions:
Heart Failure
Electric Impedance
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
REDICAE trial was designed to evaluate the safety and tolerability of diuretics withdrawal in stable, euvolemic chronic outpatients with heart failure with reduced ejection fraction. It is a single-ce...
Detailed Description
Treatment of heart failure with reduced ejection fraction (HFrEF) has improved patient survival in recent decades. Diuretics are essentials in acute decompensated heart failure, specially furosemide. ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Outpatients diagnosed of chronic HFrEF by criteria of ESC Guidelines of 2021
- Age equal or greater than 18 year-old
- Stable and euvolemic outpatients determined by clinical criteria, biomarkers (CA-125 \< 23 U/mL) and bioelectrical impedance analysis
- Left Ventricular Ejection Fraction less than 50% by echocardiography or cardiovascular magnetic resonance performed within 6 months before the screening visit
- New York Heart Association functional class I or II
- No episodes of acute decompensated heart failure within 2 months before the screening visit
- Treatment with a stable dose of diuretic for at least 1 month before the screening visit
- Optimal medical therapy with ACEI/ARNI, BB, MRA and iSGLT2 must be started to titration unless any of them were contraindicated or not tolerated
- Plasma potassium \< 5 mg/dl in the screening visit
- EXCLUSION CRITERIA:
- Acute coronary syndrome within 3 months before screening visit
- Awaiting cardiac resynchronization therapy
- Any severe valve heart disease not yet treated
- Pulmonary hypertension or any severe pulmonary disease
- End-stage chronic kidney disease (on hemodialysis). Acute kidney injury
- Severe hepatic failure or cirrhosis
- Malignancy on active treatment
- Congenital heart disease
- Awaiting cardiac transplantation
- Inability to understand and sign the informed consent
- Participation in any other interventional clinical research
Exclusion
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05964738
Start Date
December 19 2022
End Date
October 31 2024
Last Update
November 4 2024
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Córdoba (Andalucía), Spain, 14004