Clinical trial for Heart Failure With Reduced Ejection Fraction
Official title Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension
ClinicalTrials.gov ID: NCT06405555
What this study is testing
What is Midodrine Oral Tablet?
Midodrine Oral Tablet is an investigational medicine, being studied as a potential treatment for heart failure with reduced ejection fraction.
Also referred to as Midodrine hydrochloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults \>= 18 years of age.
- LVEF \<= 40 % within the last 3 months as determined by any one of: Transthoracic echocardiogram, transesophageal echocardiogram, cardiac magnetic...
- 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...
- Seated upright or supine SBP \<= 100 mmHg on two or more consecutive BP measurements separated by at least 8 hours
You likely can't join if
- 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...
- Patient within 72 hours of an acute coronary syndrome.
- Heart transplant recipient.
See the full eligibility 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
- 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 \ 60 bpm, or elevated lactate \>=3.5 mmol/L), invasive hemodynamic measurements (if available) of CI \ =15 mmHg.
- Pregnant patient.
- Anticipated patient discharge in less than two days from enrolment (ie. less than 6 anticipated doses of midodrine, if assigned by chance 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
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.