Can a blood pressure pill help heart failure patients get the meds they need?
NCT ID NCT06405555
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This pilot study tests whether midodrine, a drug that raises blood pressure, can help heart failure patients with low blood pressure tolerate standard heart medications. About 56 hospitalized adults with weak heart pumps and low blood pressure will receive midodrine or usual care for up to 5 days. The goal is to see if this approach is feasible and safe, paving the way for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Midodrine (oral tablet)
- What this could lead to
- If it works, this could provide a way to safely raise blood pressure in heart failure patients, allowing them to take guideline-directed heart medications that are often limited by low blood pressure.
- What could go wrong
- This is a small, early pilot study with only 56 participants, so results may not apply broadly. Midodrine may not effectively raise blood pressure or could cause side effects like high blood pressure or heart strain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Ottawa Heart Institute
RECRUITINGOttawa, Ontario, K1Y 4W7, Canada
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