The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2014-04-30, after 2012-11-30 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2014-04-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartventricularfailurecancertherapy
Phrases that lowered it: evaluate theand safetyparticipantsalcoholhistory -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 40 (lowers risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports marked serious: 63.8% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Blinding: double (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 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
- 73 (typical: 32)
- Sponsor's past termination rate
- 8.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 43 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2794 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 940 (typical: 412.5)
- Drug's FAERS reports marked serious
- 63.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- testosterone
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
- Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure NCT00957034 · started 2009 · scored riskier than 38% of active trials terminated
- Effects of Triiodothyronine (T3) in Ischemic Heart Failure NCT05384847 · started 2022 · scored riskier than 82% of active trials completed
- A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF) NCT06215911 · started 2024 · scored riskier than 87% of active trials completed
- Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (Cycle-2-PEF) NCT06215586 · started 2024 · scored riskier than 91% of active trials completed
- A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) NCT05592275 · started 2023 · scored riskier than 88% of active trials terminated
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.