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

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ClinicalTrials.gov Identifier: NCT03437369
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Information provided by (Responsible Party):
Marcelo Sanmartín Fernández, Hospital Universitario Ramon y Cajal

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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Drug: Ivabradine Oral Tablet Other: Standard of Care treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock (ES-FISH)
Anticipated Study Start Date : May 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Ivabradine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ivabradine
Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days
Drug: Ivabradine Oral Tablet
The target dose is 10 to 15 mg / day, administered orally in two doses
Standard of Care
The study drug will be compared with standard of Care treatment
Other: Standard of Care treatment
The study drug will be compared with the standard of Care treatment

Primary Outcome Measures :
  1. Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment. [ Time Frame: 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 Outcome Measures :
  1. Severe bradycardia [ Time Frame: 24 hours ]
    -Development of excessive bradycardia defined as heart rate (HR) <50 beats per minute

  2. Arrhythmias [ Time Frame: 24 hours ]
    New-onset of ventricular arrhythmias or atrial fibrillation

  3. Hypotension [ Time Frame: 24 hours ]
    Hypotension, defined as systolic blood pressure <90 mmHg

  4. Time to withdrawal of vasoactive drugs [ Time Frame: 30 days ]
    -Time to catecholamine withdrawal in both treatment arms (days)

  5. Time needing invasive mechanical ventilation [ Time Frame: 30 days ]
    Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment.

  6. B-type natriuretic peptide (BNP) [ Time Frame: 30 days ]
    Measured B-type natriuretic peptide (BNP) values at 30 days

  7. Left ventricular ejection fraction [ Time Frame: 30 days ]
    Change in left ventricle ejection fraction from baseline in both treatment arms (%)

  8. Cardiovascular mortality [ Time Frame: 30 days ]
    Mortality due to cardiovascular causes

  9. Total mortality [ Time Frame: 30 days ]
    Mortality from any cause

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437369

Contact: Marcelo Sanmartín Fernández, PhD +34 91 336 80 00 msanfer@me.com

Hospital Universitario Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact: Marcelo Sanmartin, MD    +34 91 336 80 00    msanfer@me.com   
Sub-Investigator: Marina Pascual Izco, MD         
Sub-Investigator: Luis Miguel Rincón Díaz, MD         
Sub-Investigator: Gonzalo Luis Alonso Salinas, MD         
Sub-Investigator: Manuel Jimenez Mena, MD         
Sub-Investigator: Asunción Camino González, MD         
Sub-Investigator: Jose Luis Zamorano, MD         
Principal Investigator: Marcelo Sanmartín Fernandez, MD         
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Principal Investigator: Marcelo Sanmartín Fernández, PhD Hospital Universitario Ramon y Cajal

Responsible Party: Marcelo Sanmartín Fernández, Director Acute Coronary Syndrome Process, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03437369     History of Changes
Other Study ID Numbers: HURamonyCajal
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Marcelo Sanmartín Fernández, Hospital Universitario Ramon y Cajal:
Ivabradine, heart rate, acute heart failure

Additional relevant MeSH terms:
Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases