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Quick tags:
- Sponsor:
Alnylam Pharmaceuticals
- Indication:
Hypertension (Cardiovascular Risk)
- Specialty:
Cardiology
- Type:
Drug (RNAi Therapeutic)
- EHR:
Practice Fusion
Site Network Description
Flourish Research operates a national clinical research network spanning cardiovascular, metabolic, neuroscience, infectious disease, and oncology trials. Their Detroit, Michigan research site was the first in the Flourish network to deploy HealthKey for the ZENITH study. Following the site's success identifying eligible patients, Flourish has since expanded HealthKey-powered screening for ZENITH across their entire clinic network.
Trial Description
The Phase 3 ZENITH study (NCT07181109) is a global, event-driven trial evaluating zilebesiran in patients with hypertension that is not adequately controlled and who have either established cardiovascular disease or are at high cardiovascular risk. Sponsored by Alnylam Pharmaceuticals in collaboration with Hoffmann-La Roche, ZENITH aims to enroll 11,000 patients across 420+ sites worldwide and will run until a pre-specified number of cardiovascular outcome events has occurred.
Zilebesiran is a subcutaneously administered RNA interference (RNAi) therapeutic targeting angiotensinogen (AGT). Unlike daily oral blood pressure medications, zilebesiran is designed to provide sustained blood pressure lowering with just twice-yearly dosing when added to standard-of-care antihypertensive therapy. The primary endpoint is time to first occurrence of a major adverse cardiovascular event, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events.
"It is one of the many novel RNAi therapeutics in our pipeline that demonstrates our long-term commitment to transforming the treatment of cardiovascular disease and improving outcomes for patients."
Weinong Guo, MD, PhD, SVP, Clinical Research, Alnylam
Challenge
Flourish Research's Detroit site had an enrollment target of 15 patients for ZENITH. Finding them meant navigating one of the most complex eligibility profiles the site had encountered.
The inclusion criteria required patients to have been treated hypertension on stable therapy with at least 2 standard-of-care antihypertensive medications (and solely for HTN), one of which must be a thiazide, thiazide-like, or loop diuretic. Patients also needed either established cardiovascular disease or high cardiovascular risk, with different age thresholds for each: 18 years or older for patients with established CVD, 55 years or older for those at high risk without established disease.
Then came the exclusions. Patients were disqualified for dual ACE inhibitor and ARB use, HbA1c greater than 10.5% within 60 days of screening, left ventricular ejection fraction below 40%, inadequate renal function, or a history of secondary hypertension. In total, HealthKey evaluated 24 distinct eligibility criteria for every patient.
A coordinator might identify a patient with documented hypertension on two medications, only to discover their last eGFR falls below the threshold, or that their most recent echocardiogram shows an LVEF of 38%. Each disqualification meant starting over with the next chart.
Solution
Flourish Research connected HealthKey to their Practice Fusion EHR. Setup took minutes. Coordinators shared the ZENITH protocol, and HealthKey's white-glove onboarding service translated all 24 inclusion and exclusion criteria into logic the AI could apply across both structured fields and unstructured clinical notes.
HealthKey screened 4,269 patients and processed 364,607 medical records, performing 104,476 individual criteria evaluations. Each match included supporting clinical evidence: the medication list confirming antihypertensive therapy and diuretic use, lab results showing HbA1c and eGFR levels, cardiology reports documenting ejection fraction, and encounter notes establishing cardiovascular disease history.
Of the 4,269 patients screened, 20 met the inclusion criteria, and 8 passed all exclusion criteria for final screening. Patients who met most criteria but had clinical edge cases were surfaced for manual review with all relevant evidence pre-assembled.
"HealthKey is so easy to use that a monkey could use it. I was able to pre-screen 20 eligible patients in under 2 hours."
Theodore Falcon, Director of Clinical Operations, Flourish Detroit
The Results
4,269 patients screened and 364,607 medical records processed
HealthKey evaluated every patient in the Practice Fusion EHR against all 24 ZENITH eligibility criteria. With an average of 85 records per patient spanning observations, lab results, medication lists, encounter notes, diagnostic reports, and clinical documents, the platform left no stone unturned.
1,280 hours of manual chart review eliminated
At a baseline of 20 minutes per manual chart review, screening 4,269 patients would have taken a single coordinator over 160 working days. HealthKey completed the work and surfaced 16 fully qualified candidates, giving the team months back to focus on enrollment and patient care.
104,476 criteria evaluations across 24 eligibility requirements
Every patient was evaluated against the full complexity of the ZENITH protocol: age thresholds stratified by cardiovascular risk, medication combination checks, lab value exclusions, and clinical history requirements.
Looking Ahead
Detroit was the first Flourish Research site to use HealthKey for ZENITH. The results proved the model: connect an EHR, translate complex protocol criteria, and surface qualified patients in hours instead of months. Flourish has since expanded HealthKey-powered screening for ZENITH across their entire research network, bringing the same speed and precision to every site in the study.
Across their organization, Flourish Research now uses HealthKey on 20+ active studies, making it a core component of their clinical trial recruitment strategy.
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