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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental | Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days |
|
| Standard of Care | Other | The study drug will be compared with standard of Care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine Oral Tablet | Drug | The target dose is 10 to 15 mg / day, administered orally in two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment. | Reduction of pulmonary wedge pressure from baseline in both treatment arms (ivabradine arm versus standard of care treatment measured by Swan Ganz balloon flotation catheter) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Severe bradycardia | -Development of excessive bradycardia defined as heart rate (HR) <50 beats per minute | 24 hours |
| Arrhythmias | New-onset of ventricular arrhythmias or atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Sanmartín Fernández, PhD | Contact | +34 91 336 80 00 | msanfer@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo Sanmartín Fernández, PhD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16214830 | Background | Tardif JC, Ford I, Tendera M, Bourassa MG, Fox K; INITIATIVE Investigators. Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina. Eur Heart J. 2005 Dec;26(23):2529-36. doi: 10.1093/eurheartj/ehi586. Epub 2005 Oct 7. | |
| 20801500 | Background | Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Standard of Care treatment | Other | The study drug will be compared with the standard of Care treatment |
|
| 24 hours |
| Hypotension | Hypotension, defined as systolic blood pressure <90 mmHg | 24 hours |
| Time to withdrawal of vasoactive drugs | -Time to catecholamine withdrawal in both treatment arms (days) | 30 days |
| Time needing invasive mechanical ventilation | Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment. | 30 days |
| B-type natriuretic peptide (BNP) | Measured B-type natriuretic peptide (BNP) values at 30 days | 30 days |
| Left ventricular ejection fraction | Change in left ventricle ejection fraction from baseline in both treatment arms (%) | 30 days |
| Cardiovascular mortality | Mortality due to cardiovascular causes | 30 days |
| Total mortality | Mortality from any cause | 30 days |
| 19944362 | Background | Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3. |
| 11245648 | Background | Lechat P, Hulot JS, Escolano S, Mallet A, Leizorovicz A, Werhlen-Grandjean M, Pochmalicki G, Dargie H. Heart rate and cardiac rhythm relationships with bisoprolol benefit in chronic heart failure in CIBIS II Trial. Circulation. 2001 Mar 13;103(10):1428-33. doi: 10.1161/01.cir.103.10.1428. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |