Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
Primary Purpose
Heart Failure NYHA Class IV
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ivabradine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure NYHA Class IV
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Cardiac biomarkers
NT-pro BNP and high sensitivity troponin
Secondary Outcome Measures
Echocardiogram
ejection fraction (%)
6-minute walk test
Distance walked (meters) in 6 minutes
Full Information
NCT ID
NCT03631654
First Posted
August 3, 2018
Last Updated
December 15, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT03631654
Brief Title
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
Official Title
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine administration--tablets given 5 mg twice daily for 2 weeks, then 7.5 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cardiac biomarkers
Description
NT-pro BNP and high sensitivity troponin
Time Frame
One month
Secondary Outcome Measure Information:
Title
Echocardiogram
Description
ejection fraction (%)
Time Frame
2 weeks, and one month
Title
6-minute walk test
Description
Distance walked (meters) in 6 minutes
Time Frame
2 weeks, and one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
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