Cardiogenic Shock
Conditions
Keywords
Ivabradine, heart rate, acute heart failure
Brief summary
This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.
Interventions
The target dose is 10 to 15 mg / day, administered orally in two doses
OTHERStandard of Care treatment
The study drug will be compared with the standard of Care treatment
Sponsors
Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment. | 24 hours | Reduction of pulmonary wedge pressure from baseline in both treatment arms (ivabradine arm versus standard of care treatment measured by Swan Ganz balloon flotation catheter) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmias | 24 hours | New-onset of ventricular arrhythmias or atrial fibrillation |
| Hypotension | 24 hours | Hypotension, defined as systolic blood pressure \<90 mmHg |
| Time to withdrawal of vasoactive drugs | 30 days | -Time to catecholamine withdrawal in both treatment arms (days) |
| Time needing invasive mechanical ventilation | 30 days | Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment. |
| Severe bradycardia | 24 hours | -Development of excessive bradycardia defined as heart rate (HR) \<50 beats per minute |
| Left ventricular ejection fraction | 30 days | Change in left ventricle ejection fraction from baseline in both treatment arms (%) |
| Cardiovascular mortality | 30 days | Mortality due to cardiovascular causes |
| Total mortality | 30 days | Mortality from any cause |
| B-type natriuretic peptide (BNP) | 30 days | Measured B-type natriuretic peptide (BNP) values at 30 days |
Countries
Spain
Contacts
Primary ContactMarcelo Sanmartín Fernández, PhD
Outcome results
None listed