Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
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| ClinicalTrials.gov Identifier: NCT03387605 |
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Recruitment Status : Unknown
Verified May 2019 by Eugenia Raichlin, Loyola University.
Recruitment status was: Recruiting
First Posted : January 2, 2018
Last Update Posted : May 23, 2019
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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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, Double Blind, Placebo Controlled single center study. |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Ivabradine
ivabradine or placebo given orally 2 times daily for 72 hours
Other Name: Corlanor |
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Placebo Comparator: Placebo
Matching placebo given PO twice per day
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Drug: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 | 708 327-2738 | mliebo@lumc.edu |
| United States, Illinois | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Eugenia Raichlin, MD | |
| Principal Investigator: | Eugenia Raichlin, MD | Loyola University |
Publications:
| Responsible Party: | Eugenia Raichlin, Associate Professor, Loyola University |
| ClinicalTrials.gov Identifier: | NCT03387605 |
| Other Study ID Numbers: |
209939 |
| First Posted: | January 2, 2018 Key Record Dates |
| Last Update Posted: | May 23, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Heart Failure Tachycardia Shock, Cardiogenic Shock Heart Diseases Cardiovascular Diseases Pathologic Processes Arrhythmias, Cardiac |
Cardiac Conduction System Disease Myocardial Infarction Myocardial Ischemia Vascular Diseases Infarction Ischemia Necrosis |