Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock
NCT03437369 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2018-02-19
Summary
This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.
Conditions
- Cardiogenic Shock
Interventions
- DRUG
-
Ivabradine Oral Tablet
The target dose is 10 to 15 mg / day, administered orally in two doses
- OTHER
-
Standard of Care treatment
The study drug will be compared with the standard of Care treatment
Sponsors & Collaborators
-
Hospital Universitario Ramon y Cajal
lead OTHER
Principal Investigators
-
Marcelo Sanmartín Fernández, PhD · Hospital Universitario Ramon y Cajal
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2019-10-31
- Completion
- 2019-10-31
- FDA Drug
- Yes
Countries
- Spain
Study Locations
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