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Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine

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ClinicalTrials.gov Identifier: NCT03387605
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Eugenia Raichlin, Loyola University

Brief Summary:

This is a randomized, double blind, single center trial to study of the effects of Ivabradine vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia (ST) (heart rate >100 beats/min).

The aim of the study will be to assess the potential of Ivabradine to slow ST and improve hemodynamics in patients with stage D HF/CS on Dobutamine treatment.


Condition or disease Intervention/treatment Phase
Heart Failure Cardiogenic Shock Tachycardia Drug: Ivabradine Drug: Placebo Phase 4

Detailed Description:

This study will explore the hypothesis that Ivabradine will decrease heart rate (HR) and improve hemodynamics in patients with advanced HF on inotropic treatment. This is a randomized, double blind, single center trial will include 40 consecutive patients admitted for Stage D HF/ CS who will require continuous infusion of Dobutamine and will develop ST (HR >100 beats/min).

Eligible patients will be randomized (1:1) using blocked randomization with random block sizes of 2 or 4 to start Ivabradine versus placebo. The procedure of randomization to receive either Ivabradine or placebo twice daily will be performed by computerized sequence generation. The hospital pharmacies will be responsible for drug randomization and dispensing, and the investigators and the patients will be blinded to the treatment option.

Ivabradine will be started 3 hours after Dobutamine initiation at dose 5 mg and further increased in 12 hours to 7.5 mg bid if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm. Increase of Ivabradine dosage will be individually stopped for reasons of safety if three episodes of minimal HRs of less than 70 beats per minute, or a drop in mean blood pressure < 60 mmHg or systolic blood pressure < 80 mmHg occur.

HR, blood pressure and invasive hemodynamics will be monitored, along with standard right heart cath and echocardiogram measurements obtained.

Patients will be followed for a total of 72 hours. The adverse events that will be collected include bradycardia, defined as a heart rate less than 70 bpm, hypotension defined as a systolic blood pressure less than 80 mmHg and any side effect requiring drug discontinuation or dose adjustment. Review of laboratory including renal, hepatic and hematologic counts will be reviewed for any significant changes due to the use of Ivabradine.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double Blind, Placebo Controlled single center study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ivabradine on Heart Rate and Hemodynamics in Patients With Stage D Heart Failure (HF)/Cardiogenic Shock on Dobutamine Treatment
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Shock
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ivabradine
Initiation at dose 5 mg PO x 1 dose and further increased in 12 hours to 7.5 mg PO twice per day if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm
Drug: Ivabradine
ivabradine or placebo given orally 2 times daily for 72 hours
Other Name: Corlanor
Placebo Comparator: Placebo
Matching placebo given PO twice per day
Drug: Placebo
matching placebo given 2 times daily for 72 hours



Primary Outcome Measures :
  1. Heart rate [ Time Frame: 72 hours ]
    Heart rate will be measured and any changes noted


Secondary Outcome Measures :
  1. cardiac index [ Time Frame: 72 hours ]
    cardiac index will be assessed by pulmonary artery catheter and any changes noted

  2. plasma brain natriuretic peptide (BNP) level [ Time Frame: 72 hours ]
    Labs will be drawn for plasma BNP blood test and any changes noted



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent for the study
  • Have current diagnosis of Ischemic and/or non-ischemic cardiomyopathy
  • Left ventricular ejection fraction (LVEF) < 30% by echo during the screening
  • Sinus rhythm with HR ≥100 bpm
  • Systolic blood pressure ≥ 90 mmHg assessed by cuff sphygmomanometer
  • CI < 2.2 L/min/m2
  • Current symptom(s) of HF (New York Heart Association (NYHA) class IV) at Screening.
  • Absence of hypovolemia, defined as a central venous pressure ≥10 mmHg and pulmonary capillary occlusion pressure ≥15 mmHg before administration of Dobutamine

Exclusion Criteria:

  • Respiratory support with mechanical ventilation
  • Circulatory mechanical support
  • Atrial pacing with the presence of sick sinus syndrome or sino-atrial block
  • Second or third degree atrioventricular (AV) block,
  • Atrial fibrillation/flutter
  • Amiodarone treatment
  • Ventricular tachycardia
  • Acute coronary syndrome
  • Bilirubin > 2.5
  • Alanine aminotransferase (ALT) >60 IE/L,
  • Serum creatinine >2.5 g/ml)
  • Fever and significant infection
  • Pregnancy
  • Anemia, Hgb < 9.0
  • Patients required treated with severe cytochrome CYP3A4 inhibitors drugs Concomitant use of strong CYP3A4 inhibitors will be avoided during the study period

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): NCT03387605


Contacts
Contact: Eugenia Raichlin, MD 708 327-2738 Eugenia.Raichlin@lumc.edu
Contact: Max Liebo, MD 708 327-2738 mliebo@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Not yet recruiting
Maywood, Illinois, United States, 60153
Contact: Eugenia Raichlin, MD         
Sponsors and Collaborators
Loyola University
Amgen
Investigators
Principal Investigator: Eugenia Raichlin, MD Loyola University

Additional Information:
Publications:

Responsible Party: Eugenia Raichlin, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03387605     History of Changes
Other Study ID Numbers: 209939
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 1, 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.: No

Additional relevant MeSH terms:
Heart Failure
Shock
Tachycardia
Shock, Cardiogenic
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmias, Cardiac
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents