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UPBEAT: Using Polygenic Scores to Guide BB Therapy in HF With Mildly Reduced EF

Using Polygenic Scores to Guide Beta-blocker Therapy for Heart Failure With Mildly Reduced Ejection Fraction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will also assess beta blockers' effect on the changes in left ventricular end-systolic volume index by MRI."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well beta blockers, a type of heart medicine, work in people with heart failure whose hearts pump out 41–50% of their blood with each beat. It uses genetic scores to look at differences in how people respond. MRI scans will measure changes in the size of the heart’s main pumping chamber after it squeezes.

This study will use polygenic scores, a tool which describes differences in genetics, to examine effectiveness of beta blocker medication in heart failure patients with ejection fraction of 41-50 percent. The study will also assess beta blockers' effect on the changes in left ventricular end-systolic volume index by MRI.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–89 years old.
  • Your latest heart test was within the past year and showed an ejection fraction above 40% and up to 50%. This is the share of blood your heart pumps out with each beat.
  • You were diagnosed with heart failure within the past year. Evidence must include at least one of these: a hospital discharge listing heart failure; an ER discharge listing it as the main problem; an outpatient heart failure record plus use of a water pill; or a BNP blood test above 35 ng/L or NTproBNP above 125 ng/L at any time.
  • You are expected to take part fully, handle the study steps, and not need long travel.

Who can't join

  • You cannot give informed consent, or the lead study doctor thinks joining is not in your best interest.
  • Your ejection fraction was ever recorded at 35% or lower, or you already take a beta blocker at 25% or more of the target dose.
  • Your top blood pressure number is above 180 or below 100 at enrollment, or your heart rate is below 70.
  • You cannot safely take any beta blocker, cannot tolerate metoprolol, or need a beta blocker for another condition, such as chest pain or a fast, uneven heartbeat.
  • You have cancer that needs active treatment, are expected to live less than one year, or have kidney failure requiring dialysis or end-stage kidney disease.
  • You have had a heart transplant or have an LVAD, a pump that helps your heart, or expect either within the next year.
  • You had a heart attack, a procedure to open heart arteries, or other heart surgery within the past 90 days, or have a heart procedure or surgery planned.
  • You cannot safely complete the MRI scans.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18-89 years * Ejection Fraction (EF) \>40% and =\<50% by any modality within 1 year (must be most recent) * Clinical diagnosis of HF within 1 year, evidenced by any one: Hospital discharge with primary or secondary HF diagnosis, ER discharge with primary diagnosis of HF, ambulatory diagnostic code for HF and diuretic use, BNP\>35 ng/L or NTproBNP \>125 ng/L at any time * Expected ability to fully participate in study (can tolerate study processes, no long travel) Exclusion Criteria: * Unable to provide informed consent * Previous documented EF =\< 35% * Currently on BB =\>25% target dose * Uncontrolled hypertension (systolic BP \> 180 at enrollment) * Has contraindications to all BB or intolerance to metoprolol * Systolic BP \< 100 or heart rate \<70 * Current cancer requiring active treatment * Heart transplant or LVAD or expected in the next year * Life expectancy \< 1 year for any reason * Dialysis dependence or ESRD * MI/ PCI or other cardiac surgery within 90 days prior to enrollment or planned in the future * Absolute indication for BB other than heart failure (e.g. tachyarrhythmia required BB for rate control, angina) * If PI decides for any reason participation in trial is not in best interest of the patient * Has a contraindication to completing MRI procedures

Study sites (1)

MI