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Compares treatment options for Heart Failure With Reduced Ejection Fraction
Official title Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
ClinicalTrials.gov ID: NCT07490067
What this study is testing
What is Metoprolol Succinate?
Metoprolol Succinate is an investigational medicine, given as an once-daily, being studied as a potential treatment for heart failure with reduced ejection fraction.
Also referred to as Lopressor, Toprol-Extended Release (XL).
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 purpose of this trial is to better understand how the beta-blocker metoprolol works in people with Heart Failure with Reduced Ejection Fraction (HFrEF) according to participants genetics. Participants will have the beta-blocker (BB) polygenic score calculated from genotype data.
- Phase 4: studies an already-approved treatment
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
- Heart Failure with Reduced Ejection Fraction (HFrEF)
- Has not taken a beta-blocker within the past 6 months (preferred), or if needed to meet enrollment target, patients that have not taken a...
- Genetic data already available to calculate the polygenic score (e.g., through participation in the Michigan Genomics Initiative (MGI) or other...
- White race
- Has been prescribed a stable dose (including no dose) of angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB)...
You likely can't join if
- Prior heart transplant or left ventricular assist device (LVAD) or planned within treatment period
- Planned implantation of a pacemaker or Cardiac Resynchronization Therapy (CRT) during treatment period
- Patients with a pacemaker that does not allow their heart rate to change in response to exercise per protocol
- Pregnant
- Systolic blood pressure \< 95 millimeters of mercury (mmHg)
- Heart rate \< 60 beats per minute
See the full eligibility criteria
- Heart Failure with Reduced Ejection Fraction (HFrEF)
- Has not taken a beta-blocker within the past 6 months (preferred), or if needed to meet enrollment target, patients that have not taken a beta-blocker in the past 3 months, or only taken a low dose of beta-blocker...
- Genetic data already available to calculate the polygenic score (e.g., through participation in the Michigan Genomics Initiative (MGI) or other genetic tests) or willingness to provide a deoxyribonucleic acid (DNA)...
- White race
- Has been prescribed a stable dose (including no dose) of angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), ARB-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 (SGLT-2)...
- Has been prescribed a stable dose (including no dose) of diuretic(s) for at least the past 2 weeks
- For women of child-bearing potential: the participant is willing to perform a pregnancy test and use a highly effective contraceptive method for at least 4 weeks prior to the start of metoprolol treatment, during the...
- Ability to understand and willing to sign a written informed consent
- Prior heart transplant or left ventricular assist device (LVAD) or planned within treatment period
- Planned implantation of a pacemaker or Cardiac Resynchronization Therapy (CRT) during treatment period
- Patients with a pacemaker that does not allow their heart rate to change in response to exercise per protocol
- Pregnant
- Systolic blood pressure \< 95 millimeters of mercury (mmHg)
- Heart rate \< 60 beats per minute
- Second (Mobitz II)- or third-degree heart block
- Cardiogenic shock
- Patients with acute decompensated heart failure requiring current hospitalization or immediate medical intervention.
- Sick sinus syndrome
- Pheochromocytoma
- Known hypersensitivity to the metoprolol succinate oral tablet used in the trial
- Hypertrophic obstructive cardiomyopathy
- Active myocarditis
- Acute coronary syndrome within the past month
- Active or uncorrected severe mitral or aortic valvular dysfunction
- Patients with known severe congenital heart disease per protocol
- Child-Pugh Class C liver disease
- Patients with end-stage renal disease (ESRD) requiring hemodialysis
- Concomitant disease that prohibits participating in Cardiopulmonary Exercise Test (CPET) per protocol
- Concomitant disease with expected survival less than the duration of the study (e.g., metastatic cancer)
- Current or planned treatment with cardiotoxic medications, including interferons and the cancer therapies per protocol
- Concurrent participation in another clinical trial that may affect participant safety or validity of data collected in this clinical trial
- Inability to take oral medication
- Unwilling or unlikely to adhere to the study procedures, as determined at the discretion of the study team, including but not limited to the following reasons:
- Psychiatric illness or other comorbidities
- Substance abuse
- Social or logistical circumstances
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 Ann Arbor, Michigan, United States. 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.