Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock (ES-FISH)

M

Madrid Health Service

Status and phase

Unknown
Phase 4

Conditions

Cardiogenic Shock

Treatments

Other: Standard of Care treatment
Drug: Ivabradine Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03437369
HURamonyCajal

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

22 participants in 2 patient groups

Ivabradine
Experimental group
Description:
Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days
Treatment:
Drug: Ivabradine Oral Tablet
Standard of Care
Other group
Description:
The study drug will be compared with standard of Care treatment
Treatment:
Other: Standard of Care treatment

Trial contacts and locations

1

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Central trial contact

Marcelo Sanmartín Fernández, PhD

Data sourced from clinicaltrials.gov

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