Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03631654

Collaborator

Stanford University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure NYHA Class IV	Drug: Ivabradine Drug: Placebos	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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

Anticipated Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cardiac biomarkers [One month]
NT-pro BNP and high sensitivity troponin

Secondary Outcome Measures

Echocardiogram [2 weeks, and one month]
ejection fraction (%)
6-minute walk test [2 weeks, and one month]
Distance walked (meters) in 6 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Maryland, Baltimore
Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Gottlieb, Professor of Medicine, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03631654

Other Study ID Numbers:

HP-00080414

First Posted:

Aug 15, 2018

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jan 5, 2022