Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405555
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-25
Brief Title:
Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension A Pilot Open-label Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDOH-HF-P
Brief Summary:
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 reportscase 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
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 reportscase 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
Detailed Description:
This will be a pilot open-label randomized controlled trial with the interventiontreatment being midodrine in hospitalized patients with HFrEF The comparatorcontrol arm will be patients following standard of care which is to undergo no further pharmacologic intervention directed at hypotension unless clinically indicated Patients who meet inclusion criteria will be randomized 11 to either midodrine group or control group which will occur at the time of recruitment In the treatment group patients will receive midodrine for a total planned duration of up to 5 days or until hospital discharge whichever comes first The midodrine will initially be started at 25 mg po TID for 1 day followed by 50 mg po TID x 1 day 75 mg po TID x 1 day and 10 mg po TID x 2 days Side effects reported by patients and any adverse drug events will be documented At the end of the inpatient study period continuation of midodrine off-label will be at the treating clinicians discretion in the treatment arm
For patients discharged home less than 1 week from the exposure period patients will be followed for 2 weeks with the Telehome monitoring program THM which is a virtual outpatient service intended to closely follow heart failure patients to monitor blood pressure heart rate weight and adverse events or side effects For patients discharged home between 1 to 2 weeks from the exposure period they will be followed for 1 week with THM For patients discharged after 2 or more weeks from the exposure period no THM follow-up will occur Frequency of THM follow-up as well as inpatient monitoring parameters is as outlined in the Data Capture section
Key clinical measurements will be obtained in both treatment and control arms including blood pressure measurements every 6 hours while awake with each measurement in the treatment arm consisting of BP measured 1 hour after the administration of midodrine dose and in the supine position For patients in the control arm a similar frequency of blood pressures will be obtained at pre-specified times NT-proBNP at the time of recruitment Day 0 prior to administration of midodrine in treatment arm and after 5 days ie Sample obtained at time of last dose at Day 4 or at Day 5 or hospital discharge whichever comes first Safety outcomes will be monitored for and assessed The study will be open-label and neither the patient nor the treating physicians will be blinded in this study
For patients discharged home less than 1 week from the exposure period patients will be followed for 2 weeks with the Telehome monitoring program THM which is a virtual outpatient service intended to closely follow heart failure patients to monitor blood pressure heart rate weight and adverse events or side effects For patients discharged home between 1 to 2 weeks from the exposure period they will be followed for 1 week with THM For patients discharged after 2 or more weeks from the exposure period no THM follow-up will occur Frequency of THM follow-up as well as inpatient monitoring parameters is as outlined in the Data Capture section
Key clinical measurements will be obtained in both treatment and control arms including blood pressure measurements every 6 hours while awake with each measurement in the treatment arm consisting of BP measured 1 hour after the administration of midodrine dose and in the supine position For patients in the control arm a similar frequency of blood pressures will be obtained at pre-specified times NT-proBNP at the time of recruitment Day 0 prior to administration of midodrine in treatment arm and after 5 days ie Sample obtained at time of last dose at Day 4 or at Day 5 or hospital discharge whichever comes first Safety outcomes will be monitored for and assessed The study will be open-label and neither the patient nor the treating physicians will be blinded in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None