Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
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|ClinicalTrials.gov Identifier: NCT03387605|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : May 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiogenic Shock Tachycardia||Drug: Ivabradine Drug: Placebo||Phase 4|
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 daily will be performed by computerized sequence generation. The hospital pharmacies will be responsible for drug randomization and dispensing, and the investigators and the patients will be blinded to the treatment option.
Ivabradine will be started 3 hours after Dobutamine initiation at dose 5 mg and further increased in 12 hours to 7.5 mg bid if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm. Increase of Ivabradine dosage will be individually stopped for reasons of safety if three episodes of minimal HRs of less than 70 beats per minute, or a drop in mean blood pressure < 60 mmHg or systolic blood pressure < 80 mmHg occur.
HR, blood pressure and invasive hemodynamics will be monitored, along with standard right heart cath and echocardiogram measurements obtained.
Patients will be followed for a total of 72 hours. The adverse events that will be collected include bradycardia, defined as a heart rate less than 70 bpm, hypotension defined as a systolic blood pressure less than 80 mmHg and any side effect requiring drug discontinuation or dose adjustment. Review of laboratory including renal, hepatic and hematologic counts will be reviewed for any significant changes due to the use of Ivabradine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double Blind, Placebo Controlled single center study.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Ivabradine on Heart Rate and Hemodynamics in Patients With Stage D Heart Failure (HF)/Cardiogenic Shock on Dobutamine Treatment|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Ivabradine
Initiation at dose 5 mg PO x 1 dose and further increased in 12 hours to 7.5 mg PO twice per day if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm
ivabradine or placebo given orally 2 times daily for 72 hours
Other Name: Corlanor
Placebo Comparator: Placebo
Matching placebo given PO twice per day
matching placebo given 2 times daily for 72 hours
- Heart rate [ Time Frame: 72 hours ]Heart rate will be measured and any changes noted
- cardiac index [ Time Frame: 72 hours ]cardiac index will be assessed by pulmonary artery catheter and any changes noted
- plasma brain natriuretic peptide (BNP) level [ Time Frame: 72 hours ]Labs will be drawn for plasma BNP blood test and any changes noted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387605
|Contact: Eugenia Raichlin, MD||708 327-2738||Eugenia.Raichlin@lumc.edu|
|Contact: Max Liebo, MD||708 firstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Eugenia Raichlin, MD|
|Principal Investigator:||Eugenia Raichlin, MD||Loyola University|