Effect of Diuretics Withdrawal in Chronic Heart Failure With Reduced Ejection Fraction (NCT05964738) | Clinical Trial Compass
CompletedPhase 2
Effect of Diuretics Withdrawal in Chronic Heart Failure With Reduced Ejection Fraction
Spain98 participantsStarted 2022-12-19
Plain-language 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-center, randomized, open-label, phase II clinical trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Dyspnea assessed by a visual analogue scale (VAS)
Timeframe: baseline - 30 days - 90 days - 180 days
Trial details
NCT IDNCT05964738
SponsorMaimónides Biomedical Research Institute of Córdoba