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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Heart Failure, Cardiogenic Shock, Tachycardia

In brief

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.

Key facts

Study ID

NCT03387605

Run by

Loyola University

People needed

40

Starts

2018-03-15

Expected to finish

2020-06-01

Last updated by the study team

2019-05-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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