Treatment of PH With Angiotensin II Receptor Blocker and Neprilysin Inhibitor in HFpEF Patients With CardioMEMS Device
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-09-20, after 2020-10-29 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-09-20. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartfailurefractionejectionlvef
Phrases that lowered it: maledailystudy willml45 -
Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: not given (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 11.9% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 64.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 206340 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past termination rate: 7.3% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 32286 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Disease area, respiratory: Yes (raises risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 41 (typical: 32)
- Sponsor's past termination rate
- 7.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 206340 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 32286 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- sacubitril, sacubitril valsartan, valsartan
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients NCT03066804 · started 2017 · scored riskier than 61% of active trials completed
- REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure NCT05353166 · started 2022 · scored riskier than 79% of active trials completed
- A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease NCT03153111 · started 2017 · scored riskier than 84% of active trials completed
- Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction NCT02468232 · started 2015 · scored riskier than 39% of active trials completed
- A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 NCT05737940 · started 2023 · scored riskier than 91% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.