Midodrine in heart failure with reduced ejection fraction and low blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, open-label, randomized trial comparing midodrine plus usual care versus usual care alone in hospitalized adults with heart failure and reduced ejection fraction who have hypotension. Participants will start at a low midodrine dose and escalate over up to five days or until discharge, with safety and adverse events monitored during hospitalization. After discharge, select patients will be followed remotely via telehome monitoring to track blood pressure, heart rate, weight, and any side effects. The study aims to determine if midodrine can enable fuller GDMT optimization and improve clinical status in this high-risk group.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Ian Paterson, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Ian Paterson, MD
• Email: dpaterson@ottawaheart.ca
• Phone: 6136967000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.