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Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes

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ClinicalTrials.gov Identifier: NCT03631654
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland, College Park

Brief Summary:

Ivabradine, a selective inhibitor of the If current in the sinoatrial node, provides heart rate reduction and leads to a reduction in heart failure hospitalizations. For this reason, the American College of Cardiology (ACC) and the American Heart Association (AHA) guidelines provide a class IIa recommendation for ivabradine in stable heart failure patients with LVEF 35% and New York Heart Association (NYHA) class II-III symptoms who are on a beta blocker at maximum tolerated dose with a resting heart rate of 70 beats per minute or greater. While ivabradine leads to improvement in outcomes in stable NYHA class II-III chronic heart failure patients, its role in class IV, stage D heart failure, and cardiogenic shock is less clear.

Ivabradine's effect on acute cardiogenic shock has been evaluated by two recent studies. In the MODIFY trial, a randomized control study evaluating ivabradine in patients with multiorgan dysfunction, the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes. However, a small prospective trial demonstrated a significant decrease in heart rate and NT-proBNP with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine. While few data investigate ivabradine's role in acute cardiogenic shock, it has yet to be studied in heart failure patients on long-term inotropic therapy. Inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias. Moreover, patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates. Ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes.

Given the benefits of ivabradine in stable chronic heart failure patients, we plan to perform a study investigating the role of ivabradine in NYHA Stage D patients on home inotropes.

Our primary objective is to analyze changes in two cardiac biomarkers, NT-proBNP and high-sensitivity troponin. Our secondary outcomes include changes in noninvasive echocardiographic hemodynamics, changes in arrhythmia burden, and heart failure symptom modification based on 6-minute walk test results.


Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class IV Drug: Ivabradine Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes: A Pilot Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Ivabradine

Arm Intervention/treatment
Placebo Comparator: Control Drug: Placebos
Placebo

Experimental: Intervention Drug: Ivabradine
Ivabradine administration--tablets given 5 mg twice daily for 2 weeks, then 7.5 mg twice daily




Primary Outcome Measures :
  1. Cardiac biomarkers [ Time Frame: One month ]
    NT-pro BNP and high sensitivity troponin


Secondary Outcome Measures :
  1. Echocardiogram [ Time Frame: 2 weeks, and one month ]
    ejection fraction (%)

  2. 6-minute walk test [ Time Frame: 2 weeks, and one month ]
    Distance walked (meters) in 6 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NYHA Stage D heart failure on 2 weeks of consecutive IV dobutamine or milrinone
  • Followed at UMMC outpatient heart failure clinic or admitted to advanced heart failure inpatient service and planning to follow up at UMMC outpatient heart failure clinic

Exclusion Criteria:

  • Patients who are already on ivabradine
  • Patients who are not willing to follow-up with UMMC outpatient heart failure team

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Responsible Party: Steve Gottlieb, Professor of Medicine, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03631654    
Other Study ID Numbers: HP-00080414
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases