Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 10% 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
Completed on 2015-03-31, after 2014-04-30 start.
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 2015-03-31. 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: m2kgcrossoverassess50
Phrases that lowered it: effecttherapy20vasculartrial -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 3 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: sponsor investigator (raises risk) · Design
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports with a death: 15.6% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Minimum age: 50 (raises risk) · Who can join
-
Blinding: triple (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 90.1% (raises risk) · Drug's FDA history
-
Disease area, cardiovascular: 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 50 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 5977 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 745 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- isosorbide mononitrate
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
- Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF NCT02742129 · started 2016 · scored riskier than 43% of active trials completed
- Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) NCT02713126 · started 2016 · scored riskier than 69% of active trials completed
- Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure NCT04956809 · started 2021 · scored riskier than 66% of active trials completed
- randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure NCT02900378 · started 2016 · scored riskier than 47% of active trials completed
- Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) NCT00763867 · started 2008 · scored riskier than 84% 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.