NCT05964738CompletedPhase 2
Effect of Diuretics Withdrawal in Chronic Heart Failure With Reduced Ejection Fraction
Safety and Tolerability of Diuretics Withdrawal in Heart Failure With Reduced Ejection Fraction. REDICAE Trial.
Source: ClinicalTrials.gov · Last updated 4 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 28 Jun 2023
- Start date
- Dec 2022
- Primary completion date
- Oct 2024
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Diseases
- Heart failure
- NCT number
- NCT05964738
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 98
- From Dec 2022 to the primary completion date, Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute coronary syndrome within 3 months before screening visit
Other illness
- 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
Other
- Inability to understand and sign the informed consent
- Participation in any other interventional clinical research
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.