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โ† Trials
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Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllOttawa Heart Institute Research Corporation
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In plain words

What the trial is, and whether it could suit you

The evidence-based pharmacologic treatments available for patients with heart failure with reduced ejection fraction (HFrEF) has been established over the last few decades of cardiovascular research. These treatments, termed Foundational Guideline-Directed-Medical Therapies (GDMT), prolong patient life, improve patient-reported symptoms, and reduce hospitalizations for heart failure. A direct effect of most medication classes encompassed within GDMT is the reduction in blood pressure due to their mechanisms of action. In addition, as patients with HFrEF become more advanced in their disease, a significant proportion develop hypotension related to pump failure and autonomic dysfunction, amongst other possible mechanisms. As a result, a significant proportion of HFrEF patients are not optimized on GDMT with hypotension as their limiting barrier that would otherwise have served to improve t

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults \>= 18 years of age. * LVEF \<= 40 % within the last 3 months as determined by any one of: Transthoracic echocardiogram, transesophageal echocardiogram, cardiac magnetic resonance imaging, MUGA scan, angiogram with left ventriculogram. * AHA/ACC Stage B or C Heart Failure * Hospitalized patients in the ward setting OR in the cardiac intensive care unit (who are \>= 48 hours after their last dose of vasopressor or inotrope). * Seated upright or supine SBP \<= 100 mmHg on two or more consecutive BP measurements separated by at least 8 hours Exclusion Criteria: * Patient OR substitute decision-maker (SDM) unwilling or unable to provide informed consent * Documented allergy or intolerance to midodrine * Treatment for active infection (either documented infection or empiric treatment) with antimicrobials at the time of recruitment. * Current use OR any use within the last 48 hours of an intravenous inotrope or vasopressor medication OR the need for IV inotrope or vasoproessor use to treat hypotension * Patient within 72 hours of an acute coronary syndrome. * Heart transplant recipient. * Presence of temporary or durable mechanical circulatory support device. * Severe valvular disease expected to be intervened upon during the incident hospitalization. * Hyperkalemia \>= 5.5 mmol/L. * Baseline eGFR (as calculated by the CKD-EPI method) \<= 20 mL/min/1.73 m2 as measured within the last 3 months. * A treatable cause for hypotension, including but not limited to: hypovolemia (eg. Bleeding, overdiuresis, poor oral intake), obstructive shock, sepsis, adrenal insufficiency. * Clinical diagnosis of ongoing cardiogenic shock, or diagnosed as defined in SHOCK trial: sBP \<= 90 mmHg with evidence of end-organ hypoperfusion (cool extremities, urine output \< 30 mL/hr, HR \> 60 bpm, or elevated lactate \>=3.5 mmol/L), invasive hemodynamic measurements (if available) of CI \<= 2.2 L/min/m2 and a pulmonary capillary wedge pressure (PCWP) of \>=15 mmHg. * Pregnant patient. * Anticipated patient discharge in less than two days from enrolment (ie. less than 6 anticipated doses of midodrine, if randomized to treatment/intervention arm). * Acute brain pathology (including, but not limited to intracranial hemorrhage or hematoma) in which most-responsible clinician deems it unsafe to augment blood pressure. * Untreated thyrotoxicosis * Acute or acute on chronic liver failure * Patient unable to take oral medications * Bradycardia with resting heart rate less than 50 beats per minute. * Patients on an equivalent dose of Lasix \>= 80 mg IV BID
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What it tests

  • Midodrine Oral Tablet
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Where

1 site
University of Ottawa Heart Institute
Ottawa, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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