Midodrine for Heart Failure and Low Blood Pressure
(MIDOH-HF-P Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 their heart function, heart failure symptoms, and mortality. Currently, there does not exist any evidence-based strategies to address the problem of hypotension in HFrEF patients who are not optimized on GDMT.
Midodrine is an alpha-adrenergic agonist (α1-AR) that exerts its effects on peripheral venous and arteriolar vasculature to increase blood pressure. This medication has been used off-label by some clinicians in the hypotensive HFrEF population to increase blood pressure and has been reported to have beneficial effects in improving GDMT utilization as well as increasing left ventricular ejection fraction (LVEF) in published case reports/case series. There does not exist any randomized prospective data on the use of midodrine in the hypotensive HFrEF population. The investigators' objective is to complete the first open-label, randomized control trial of midodrine in the hypotensive HFrEF population to demonstrate feasibility in performing a trial in this patient population and to show efficacy in increasing blood pressure without associated harm. The results of this trial will be used as the foundation and rationale for future studies assessing the impact of midodrine use on GDMT utilization as well as hard cardiovascular outcomes in the hypotensive HFrEF population, including hospitalizations for heart failure and mortality.
Who Is on the Research Team?
Ian Paterson, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults hospitalized with heart failure and reduced ejection fraction (LVEF ≤ 40%), who have low blood pressure (systolic BP ≤ 100 mmHg) measured at least twice. Participants must be stable, not on strong IV medications to raise blood pressure for at least 48 hours.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Midodrine
Trial Overview
The study tests whether midodrine tablets can safely raise blood pressure in people with heart failure and low blood pressure. It is an open-label, randomized controlled trial comparing those who receive midodrine to those who do not.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to receive midodrine for up to 5 days in hospital at escalating doses starting at 2.5 mg po TID x 1 day, 5.0 mg po TID x 1 day, 7.5 mg po TID x 1 day, 10 mg po TID x 2 days. Patients may be discharged from hospital prior to completion of the full 5 day protocol. All patients in the midodrine treatment arm will receive otherwise usual standard of care treatments.
Patients randomized to the control arm will receive usual standard of care treatments without addition of midodrine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor
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