Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
NCT ID: NCT03387605
Last Updated: 2019-05-23
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
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-15
Study Completion Date
2020-06-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Heart Failure
Cardiogenic Shock
Tachycardia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, Double Blind, Placebo Controlled single center study.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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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
Group Type
ACTIVE_COMPARATOR
Ivabradine
Intervention Type
DRUG
ivabradine or placebo given orally 2 times daily for 72 hours
Placebo
Matching placebo given PO twice per day
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
matching placebo given 2 times daily for 72 hours
Interventions
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Ivabradine
ivabradine or placebo given orally 2 times daily for 72 hours
Intervention Type
DRUG
Placebo
matching placebo given 2 times daily for 72 hours
Intervention Type
DRUG
Other Intervention Names
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Corlanor
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Amgen
INDUSTRY
Sponsor Role
collaborator
Loyola University
OTHER
Sponsor Role
lead
Responsible Party
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Eugenia Raichlin
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Eugenia Raichlin, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Eugenia Raichlin, MD
Role: primary
References
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Reynolds HR, Hochman JS. Cardiogenic shock: current concepts and improving outcomes. Circulation. 2008 Feb 5;117(5):686-97. doi: 10.1161/CIRCULATIONAHA.106.613596. No abstract available.
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Metra M, Nodari S, D'Aloia A, Muneretto C, Robertson AD, Bristow MR, Dei Cas L. Beta-blocker therapy influences the hemodynamic response to inotropic agents in patients with heart failure: a randomized comparison of dobutamine and enoximone before and after chronic treatment with metoprolol or carvedilol. J Am Coll Cardiol. 2002 Oct 2;40(7):1248-58. doi: 10.1016/s0735-1097(02)02134-4.
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Wynsen JC, O'Brien PD, Warltier DC. Zatebradine, a specific bradycardic agent, enhances the positive inotropic actions of dobutamine in ischemic myocardium. J Am Coll Cardiol. 1994 Jan;23(1):233-41. doi: 10.1016/0735-1097(94)90526-6.
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Aidonidis I, Brachmann J, Rizos I, Zacharoulis A, Stavridis I, Toutouzas P, Kubler W. Electropharmacology of the bradycardic agents alinidine and zatebradine (UL-FS 49) in a conscious canine ventricular arrhythmia model of permanent coronary artery occlusion. Cardiovasc Drugs Ther. 1995 Aug;9(4):555-63. doi: 10.1007/BF00878087.
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Hettrick DA, Pagel PS, Lowe D, Tessmer JP, Warltier DC. Increases in inotropic state without change in heart rate: combined use of dobutamine and zatebradine in conscious dogs. Eur J Pharmacol. 1996 Dec 5;316(2-3):237-44. doi: 10.1016/s0014-2999(96)00688-7.
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Neustein SM, Dimich I, Shiang H, Mezrow C. Role of zatebradine and propranolol in attenuation of tachycardia produced by dobutamine in pigs. Acta Anaesthesiol Scand. 1997 Aug;41(7):849-52. doi: 10.1111/j.1399-6576.1997.tb04799.x.
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Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
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BACKGROUND
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.
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Henri C, O'Meara E, De Denus S, Elzir L, Tardif JC. Ivabradine for the treatment of chronic heart failure. Expert Rev Cardiovasc Ther. 2016;14(5):553-61. doi: 10.1586/14779072.2016.1165092. Epub 2016 Mar 28.
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Tardif JC, O'Meara E, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K; SHIFT Investigators. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J. 2011 Oct;32(20):2507-15. doi: 10.1093/eurheartj/ehr311. Epub 2011 Aug 29.
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Fang Y, Debunne M, Vercauteren M, Brakenhielm E, Richard V, Lallemand F, Henry JP, Mulder P, Thuillez C. Heart rate reduction induced by the if current inhibitor ivabradine improves diastolic function and attenuates cardiac tissue hypoxia. J Cardiovasc Pharmacol. 2012 Mar;59(3):260-7. doi: 10.1097/FJC.0b013e31823e5e01.
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Mulder P, Barbier S, Chagraoui A, Richard V, Henry JP, Lallemand F, Renet S, Lerebours G, Mahlberg-Gaudin F, Thuillez C. Long-term heart rate reduction induced by the selective I(f) current inhibitor ivabradine improves left ventricular function and intrinsic myocardial structure in congestive heart failure. Circulation. 2004 Apr 6;109(13):1674-9. doi: 10.1161/01.CIR.0000118464.48959.1C. Epub 2004 Feb 23.
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Reil JC, Tardif JC, Ford I, Lloyd SM, O'Meara E, Komajda M, Borer JS, Tavazzi L, Swedberg K, Bohm M. Selective heart rate reduction with ivabradine unloads the left ventricle in heart failure patients. J Am Coll Cardiol. 2013 Nov 19;62(21):1977-1985. doi: 10.1016/j.jacc.2013.07.027. Epub 2013 Aug 7.
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Cavusoglu Y, Mert U, Nadir A, Mutlu F, Morrad B, Ulus T. Ivabradine treatment prevents dobutamine-induced increase in heart rate in patients with acute decompensated heart failure. J Cardiovasc Med (Hagerstown). 2015 Sep;16(9):603-9. doi: 10.2459/JCM.0000000000000033.
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Roubille F, Lattuca B, Busseuil D, Leclercq F, Davy JM, Rheaume E, Tardif JC. Is ivabradine suitable to control undesirable tachycardia induced by dobutamine in cardiogenic shock treatment? Med Hypotheses. 2013 Aug;81(2):202-6. doi: 10.1016/j.mehy.2013.05.002. Epub 2013 May 26.
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Gallet R, Ternacle J, Damy T, Guendouz S, Bremont C, Seemann A, Gueret P, Dubois-Rande JL, Lim P. Hemodynamic effects of Ivabradine in addition to dobutamine in patients with severe systolic dysfunction. Int J Cardiol. 2014 Sep 20;176(2):450-5. doi: 10.1016/j.ijcard.2014.07.093. Epub 2014 Aug 1.
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Related Links
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http://medicontenidosporcile.files.wordpress.com/2016/03/curr-reserch-cardiol.pdf
article: Safety, tolerability and efficacy of ivabradine for control of sinus tachycardia in patients undergoing inotropic therapy
Other Identifiers
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209939
Identifier Type: -
Identifier Source: org_study_id
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