Overview

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

Status:
Unknown status
Trial end date:
2020-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Loyola University
Collaborator:
Amgen
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