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

Primary Purpose

Cardiogenic Shock

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Ivabradine Oral Tablet

Standard of Care treatment

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Ivabradine, heart rate, acute heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ivabradine

Standard of Care

Arm Description

Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days

The study drug will be compared with standard of Care treatment

Outcomes

Primary Outcome Measures

Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.

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

Severe bradycardia

-Development of excessive bradycardia defined as heart rate (HR) <50 beats per minute

Arrhythmias

New-onset of ventricular arrhythmias or atrial fibrillation

Hypotension

Hypotension, defined as systolic blood pressure <90 mmHg

Time to withdrawal of vasoactive drugs

-Time to catecholamine withdrawal in both treatment arms (days)

Time needing invasive mechanical ventilation

Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment.

B-type natriuretic peptide (BNP)

Measured B-type natriuretic peptide (BNP) values at 30 days

Left ventricular ejection fraction

Change in left ventricle ejection fraction from baseline in both treatment arms (%)

Cardiovascular mortality

Mortality due to cardiovascular causes

Total mortality

Mortality from any cause

Full Information

NCT ID

NCT03437369

First Posted

January 15, 2018

Last Updated

February 12, 2018

Sponsor

Hospital Universitario Ramon y Cajal

1. Study Identification

Unique Protocol Identification Number

NCT03437369

Brief Title

Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock

Acronym

ES-FISH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 2018 (Anticipated)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario Ramon y Cajal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Shock

Keywords

Ivabradine, heart rate, acute heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ivabradine

Arm Type

Experimental

Arm Description

Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days

Arm Title

Standard of Care

Arm Type

Other

Arm Description

The study drug will be compared with standard of Care treatment

Intervention Type

Drug

Intervention Name(s)

Ivabradine Oral Tablet

Intervention Description

The target dose is 10 to 15 mg / day, administered orally in two doses

Intervention Type

Other

Intervention Name(s)

Standard of Care treatment

Intervention Description

The study drug will be compared with the standard of Care treatment

Primary Outcome Measure Information:

Title

Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.

Description

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)

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Severe bradycardia

Description

-Development of excessive bradycardia defined as heart rate (HR) <50 beats per minute

Time Frame

24 hours

Title

Arrhythmias

Description

New-onset of ventricular arrhythmias or atrial fibrillation

Time Frame

24 hours

Title

Hypotension

Description

Hypotension, defined as systolic blood pressure <90 mmHg

Time Frame

24 hours

Title

Time to withdrawal of vasoactive drugs

Description

-Time to catecholamine withdrawal in both treatment arms (days)

Time Frame

30 days

Title

Time needing invasive mechanical ventilation

Description

Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment.

Time Frame

30 days

Title

B-type natriuretic peptide (BNP)

Description

Measured B-type natriuretic peptide (BNP) values at 30 days

Time Frame

30 days

Title

Left ventricular ejection fraction

Description

Change in left ventricle ejection fraction from baseline in both treatment arms (%)

Time Frame

30 days

Title

Cardiovascular mortality

Description

Mortality due to cardiovascular causes

Time Frame

30 days

Title

Total mortality

Description

Mortality from any cause

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcelo Sanmartín Fernández, PhD

Phone

+34 91 336 80 00

msanfer@me.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelo Sanmartín Fernández, PhD

Organizational Affiliation

Hospital Universitario Ramon y Cajal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcelo Sanmartin, MD

Phone

+34 91 336 80 00

msanfer@me.com

First Name & Middle Initial & Last Name & Degree

Marina Pascual Izco, MD

First Name & Middle Initial & Last Name & Degree

Luis Miguel Rincón Díaz, MD

First Name & Middle Initial & Last Name & Degree

Gonzalo Luis Alonso Salinas, MD

First Name & Middle Initial & Last Name & Degree

Manuel Jimenez Mena, MD

First Name & Middle Initial & Last Name & Degree

Asunción Camino González, MD

First Name & Middle Initial & Last Name & Degree

Jose Luis Zamorano, MD

First Name & Middle Initial & Last Name & Degree

Marcelo Sanmartín Fernandez, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16214830

Citation

Tardif JC, Ford I, Tendera M, Bourassa MG, Fox K; INITIATIVE Investigators. Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina. Eur Heart J. 2005 Dec;26(23):2529-36. doi: 10.1093/eurheartj/ehi586. Epub 2005 Oct 7.

Results Reference

background

PubMed Identifier

20801500

Citation

Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. Erratum In: Lancet. 2010 Dec 11;376(9757):1988. Lajnscak, M [corrected to Lainscak, M]; Rabanedo, I Roldan [corrected to Rabadan, I Roldan]; Leva, M [corrected to Ieva, M].

Results Reference

background

PubMed Identifier

19944362

Citation

Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3.

Results Reference

background

PubMed Identifier

11245648

Citation

Lechat P, Hulot JS, Escolano S, Mallet A, Leizorovicz A, Werhlen-Grandjean M, Pochmalicki G, Dargie H. Heart rate and cardiac rhythm relationships with bisoprolol benefit in chronic heart failure in CIBIS II Trial. Circulation. 2001 Mar 13;103(10):1428-33. doi: 10.1161/01.cir.103.10.1428.

Results Reference

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Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock

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