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

Launched by LOYOLA UNIVERSITY · Dec 22, 2017

Keywords

ClinConnect Summary

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 d...

Gender

ALL

Eligibility 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