Heart Failure With Reduced Ejection Fraction study: Midodrine Oral Tablet
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?
This is an investigational oral tablet being studied to help manage low blood pressure in patients with heart failure with reduced ejection fraction. It is designed to tighten blood vessels to raise blood pressure.
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
- This study is testing whether midodrine can safely raise blood pressure. It aims to see if this helps people take their usual heart medicines.
- Who it's for
- You may be able to join if you have heart failure with a weak pump and low blood pressure.
- What's involved
- You would take midodrine or a pretend pill. You would visit the clinic for checks on your blood pressure and heart health.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- 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 is enrolling
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.