An interventional study of Beta blocker in Heart Failure and Polygenic Score, sponsored by David Lanfear. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by David Lanfear · Not applicable, Interventional, and Treatment
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.
Heart failure (HF) is a major public health problem that displays wide variation in progression and response to therapy. Beta-blockers (BB) are the cornerstone of treatment for HF reduced ejection fraction (HFrEF) but only \~25% of patients experience a marked and sustained ejection fraction (EF) response, and they can have unwanted side effects (fatigue, depression, erectile dysfunction, others). The potential for Precision Medicine to improve HF care is great, but despite proof of concept, actionable ways are still lacking to use genomic or biomarker strategies to predict response to typical treatment. An important limitation of pharmacogenetics to date is that most studies used candidate gene approaches, assuming other loci are not meaningful. Unbiased approaches (e.g. genome-wide [GW] association) overcome this, but the typical analysis requires stringent significance levels which result in missing potentially important sources of variation. Common complex disease and drug responses are unlikely to be under strong single-loci influence (e.g., Mendelian disease), and instead are likely influenced by many loci that have relatively weak effects (i.e., polygenicity); such phenotypes are better tackled with approaches like polygenic risk scores. The PI has developed and validated a polygenic score for BB drug-response (in terms of mortality benefit) in HF for European ancestry patients and is currently developing a new score for diverse ancestries, particular African ancestry and admixed populations. To move this new paradigm for precision medicine forward to clinical utility, a randomized trial of BB by genomic (polygenic score) subgroups is needed. Moreover, pivotal trials of BB in HF excluded patients with mildly reduced EF (HFmEF, 40-50%), representing a public health issue of significant size (an estimated prevalence of 1.6M Americans) where currently BB may or may not be used and with limited data to guide who should or should not receive this key therapy. HFmEF patients have abnormal systolic function, high event rates, share many characteristics with HFrEF, and the polygenic response score correctly differentiates responders from non-responders in this group, making them the ideal group of patients in which to test genomically targeted BB treatment in a clinical trial. This pilot study will demonstrate feasibility of a future phase 2 study. That study, if successful would potentially revolutionize HF care by demonstrating signs of efficacy in terms of polygenic drug targeting.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with David Lanfear as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will be dispensed and titrated on beta blocker according to study protocol.
Other: Beta blocker
This group will be dispensed and titrated on placebo according to study protocol.
Participants randomized to intervention will be dosed and titrated on beta blocker according to study protocol.
Change in left ventricle end systolic volume index
LVESVi, measured in mL per square meter; assessed by cardiac MRI
Time frame: Within 6 months of randomization
Other MRI ventricular performance characteristics: Left ventricular EF
Left ventricular EF, measured in percentage
Time frame: Baseline and within 6 months of randomization
Other MRI ventricular performance characteristics: Left ventricular end-diastolic volume index
Left ventricular end-diastolic volume index (LVEDVi) as assessed by cardiac MRI, measured in mL per square meter
Time frame: Baseline and within 6 months of randomization
Clinical effects: blood pressure
Change in Blood pressure, measured in mmHg
Time frame: Baseline through exit visit, an interval of approximately 6 months
Clinical effects: Heart rate
Change in Heart rate, measured in beats per minute
Time frame: Baseline through exit visit, an interval of approximately 6 months
Change in NT-proBNP levels
Blood test for biomarker level of N-terminal pro Brain natriuretic protein, measured in ng/L
Time frame: Baseline and within 6 months of randomization
Quality of life status
Summary score of KCCQ
Time frame: Baseline and monthly for duration of approximately 6 months
Functional status
Change in 6-minute-walk-test, measured in meters
Time frame: Baseline through exit visit, an interval of approximately 6 months
Clinical safety events
Measured in all-cause mortality
Time frame: Baseline through 30 days following completion of exit visit
Clinical safety events
Measured in heart failure hospitalizations and emergency room visits
Time frame: Baseline through 30 days following completion of exit visit
Clinical safety events
Measured in symptomatic hypotension or syncope
Time frame: Baseline through 30 days following completion of exit visit
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