Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT03437369
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (LVEF ≤ 40%) in sinus rhythm, baseline HR ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the Cardiological Intensive Care Unit.
* Pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion.
* Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure \> 90 mm Hg.
* Patient's signature on the consent form.
Exclusion Criteria:
* Previous treatment with ivabradine (\< 48 hours).
* Known hypersensitivity to ivabradine.
* Cardiac rhythm different from sinus rhythm.
* Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (AV) block.
* Severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis.
* QT interval higher than 450 ms.
* Sepsis as a probable mechanism of tachycardia and hypotension.
* Need for urgent cardiac surgery, planned within 72 hours of possible inclusion.
* Severe aortic stenosis or severe valvular disease that requires surgical correction.
* Patient must not have received an IV bolus of furosemide immediately before the baseline hemodynamic assessment.
* Severe hepatic insufficiency.
* Patient must not be participating in another clinical trial.
* Concomitant use of potent CYP3A4 inhibitors.
* Acute anemia or hypovolemia uncorrected.
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03437369
Study Brief:
Protocol Section:
NCT03437369