Status:
UNKNOWN
Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Amgen
Conditions:
Heart Failure
Cardiogenic Shock
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 r...
Detailed Description
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, s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03387605
Start Date
March 15 2018
End Date
June 1 2020
Last Update
May 23 2019
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153