ELAM-PH2-HFPEF-ADHERENCE — structured trial abstract
ELAM-PH2-HFPEF adherence and persistence analysis — SS-31 (elamipretide)
Institute-constructed programme record. This document is not a report of a published trial. It is a record the Institute has constructed to represent an instalment, sub-study or extension of a real development programme, published in order to carry a methodological point that the parent trial report does not address. No effect estimate on this page is attributable to any publication, and its reference-list entry carries a programme-record label rather than a citation. The policy governing these records was settled through a public comment period.
§1Structured abstract
§1.1Objective
To evaluate SS-31 (elamipretide) in heart failure with preserved ejection fraction and obesity, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Observational cohort analysis
- Masking
- Not applicable
- Phase
- Phase 2
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- As stated in the parent protocol
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Proportion remaining on randomised treatment at the primary analysis timepoint, and time to discontinuation
§1.4Principal result
This is an Institute-constructed programme record and reports no effect estimate. Its purpose is set out in §1.6.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Constructed | Constructed by the Institute for this programme record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Not held | No result is reproduced. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |