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NCT06099665: ALERT
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
NA trial testing Automated alert in Aortic Valve Stenosis in 2,118 participants. Completed in 1 December 2025.
1 December 2025
Quick facts
| Lead sponsor | Tempus AI |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 2,118 |
| Start date | 27 August 2024 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Automated alert
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
- Mitral Regurgitation — all drugs for Mitral Regurgitation →
Sponsor
Tempus AI — full company profile →
Who can join
18 and older, any sex, with Aortic Valve Stenosis or Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). This study will evaluate the impact of Tempus Next's automated notifications on: (1) Transcatheter or surgical procedure for AS or MR; and (2) Clinic visit with at least one member of the Multidisciplinary Heart Team (including time to evaluation) for patients with definitive or possible severe AS or MR on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography. The primary question that will be answered: Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis and severe mitral regurgitation? The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Automated Alerts to Improve Timely Evaluation and Treatment of Valvular Heart Disease: The ALERT Trial.
Batchelor WB, Lindman BR, Coylewright M, Keller A, et al · · 2026 · cited 1× · PMID 42059855 · DOI 10.1016/j.jacc.2026.03.037 -
A Randomized Trial Evaluating Automated Notifications for the Identification and Treatment of Aortic Stenosis and Mitral Regurgitation: The ALERT Study.
Batchelor WB, Lindman BR, Coylewright M, Keller A, et al · · 2026 · PMID 42051888 · DOI 10.1016/j.jscai.2025.104040
Verify or expand the search:
- PubMed search for NCT06099665
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
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Other Tempus AI trials
Trials by the same sponsor.
- NCT06163534 — A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC) · recruiting
- NCT06207032 — TEMPUS ARIES: A Biobank Registry Platform Study in Oncology · recruiting
- NCT06018753 — Umbrella Study for Analysis of Data Related to Patients With Cancer · active not recruiting
- NCT05169437 — Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors · Phase 2 · terminated
- NCT05179824 — Tempus Priority Study: A Pan-tumor Observational Study · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06099665 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tempus AI
- Last refreshed: 6 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06099665.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing