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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Ivabradine

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

Group Type EXPERIMENTAL

Ivabradine Oral Tablet

Intervention Type DRUG

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

Group Type OTHER

Standard of Care treatment

Intervention Type OTHER

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

Interventions

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Ivabradine Oral Tablet

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

Intervention Type DRUG

Standard of Care treatment

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No