Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine (NCT03387605) | Clinical Trial Compass
UnknownPhase 4
Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
United States40 participantsStarted 2018-03-15
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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