NCT03437369

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

January 15, 2018

Last Update Submit

February 12, 2018

Conditions

Cardiogenic Shock

Keywords

Ivabradine, heart rate, acute heart failure

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 hours

Secondary Outcomes (9)

  • Severe bradycardia

    24 hours

  • Arrhythmias

    24 hours

  • Hypotension

    24 hours

  • Time to withdrawal of vasoactive drugs

    30 days

  • Time needing invasive mechanical ventilation

    30 days

  • +4 more secondary outcomes

Study Arms (2)

Ivabradine

EXPERIMENTAL

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

Drug: Ivabradine Oral Tablet

Standard of Care

OTHER

The study drug will be compared with standard of Care treatment

Other: Standard of Care treatment

Interventions

Ivabradine Oral TabletDRUG

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

Ivabradine
Standard of Care treatmentOTHER

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure \> 90 mm Hg.
  • Patient's signature on the consent form.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (4)

  • 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.

    PMID: 16214830BACKGROUND

  • 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.

    PMID: 20801500BACKGROUND

  • 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.

    PMID: 19944362BACKGROUND

  • 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.

    PMID: 11245648BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Marcelo Sanmartín Fernández, PhD

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo Sanmartín Fernández, PhD

CONTACT

+34 91 336 80 00msanfer@me.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Acute Coronary Syndrome Process

Study Record Dates

First Submitted

January 15, 2018

First Posted

February 19, 2018

Study Start

May 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)