PARADIGM-HF

NCT01035255 · 18 criteria · 2008 - 2010, 2011 - 2013

Hospital patients

364,627

Qualified by structured

15,602

Qualified by LLM

5,785

Enrolled

Disqualified by structured

349,025

Awaiting LLM

460

Disqualified by LLM

9,357

Criteria

Inclusion

Incl 1

Informed consent

screening visit

Incl 2a

Heart failure diagnosis (ICD I50 / 428)

structured

Incl 2b

Adult ≥ 18

structured

Incl 3a

llm

Incl 3b

llm

Incl 3c

llm

Incl 4

llm

Incl 5

llm

Exclusion

Excl 1

Other investigational drugs within 30 days / 5 half-lives

screening visit

Excl 2

ACEi or ARB hypersensitivity

screening visit

Excl 3

Previous intolerance at target dose

screening visit

Excl 4a

Documented angioedema (ICD T78.3 / 995.1)

structured

Excl 4b

llm

Excl 5

Concurrent ACEi + ARB

screening visit

Excl 6

Currently acute decompensated heart failure

screening visit

Excl 7

Symptomatic hypotension and/or SBP < 100 mmHg

screening visit

Excl 8

eGFR < 30 mL/min/1.73 m²

screening visit

Excl 9

Serum K+ > 5.2 mmol/L

screening visit

460 pre-note candidates ready for review

Run the local Gemma 4 screener over their chart notes.

Each note checked against 6 LLM criteria:

Patients:

Show:all disqualified pre-note note candidate enrolled

Patient	Age	Sex	State	Incl 3a	Incl 3b	Incl 3c	Incl 4	Incl 5	Excl 4b
demo_102	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_105	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_110	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_130	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_144	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_148	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	PASS
demo_101	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	UNKNOWN
demo_104	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	UNKNOWN
demo_111	—	—	note_candidate	PASS	FAIL	PASS	PASS	PASS	PASS
demo_118	—	—	note_candidate	FAIL	PASS	PASS	PASS	PASS	PASS
demo_119	—	—	note_candidate	PASS	UNKNOWN	PASS	PASS	PASS	PASS
demo_122	—	—	note_candidate	PASS	PASS	PASS	FAIL	PASS	PASS
demo_123	—	—	note_candidate	PASS	FAIL	PASS	PASS	PASS	PASS
demo_125	—	—	note_candidate	PASS	PASS	PASS	UNKNOWN	PASS	PASS
demo_126	—	—	note_candidate	PASS	UNKNOWN	PASS	PASS	PASS	PASS
demo_127	—	—	note_candidate	PASS	PASS	PASS	PASS	FAIL	PASS
demo_129	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	UNKNOWN
demo_133	—	—	note_candidate	PASS	PASS	PASS	FAIL	PASS	PASS
demo_135	—	—	note_candidate	PASS	PASS	FAIL	PASS	PASS	PASS
demo_136	—	—	note_candidate	PASS	PASS	PASS	FAIL	PASS	PASS
demo_137	—	—	note_candidate	PASS	PASS	PASS	PASS	PASS	FAIL
demo_147	—	—	note_candidate	PASS	PASS	PASS	PASS	UNKNOWN	PASS
demo_106	—	—	note_candidate	PASS	FAIL	PASS	UNKNOWN	PASS	PASS
demo_108	—	—	note_candidate	PASS	PASS	PASS	FAIL	PASS	UNKNOWN
demo_109	—	—	note_candidate	UNKNOWN	UNKNOWN	PASS	PASS	PASS	PASS
demo_112	—	—	note_candidate	PASS	PASS	PASS	PASS	UNKNOWN	FAIL
demo_113	—	—	note_candidate	PASS	UNKNOWN	PASS	PASS	UNKNOWN	PASS
demo_117	—	—	note_candidate	FAIL	PASS	PASS	PASS	FAIL	PASS
demo_121	—	—	note_candidate	PASS	PASS	PASS	FAIL	PASS	UNKNOWN
demo_124	—	—	note_candidate	PASS	PASS	PASS	UNKNOWN	UNKNOWN	PASS
demo_128	—	—	note_candidate	PASS	UNKNOWN	PASS	PASS	PASS	UNKNOWN
demo_134	—	—	note_candidate	PASS	PASS	PASS	UNKNOWN	UNKNOWN	PASS
demo_140	—	—	note_candidate	PASS	PASS	FAIL	PASS	PASS	FAIL
demo_141	—	—	note_candidate	PASS	UNKNOWN	PASS	PASS	UNKNOWN	PASS
demo_143	—	—	note_candidate	PASS	PASS	UNKNOWN	PASS	PASS	FAIL
demo_145	—	—	note_candidate	PASS	PASS	UNKNOWN	UNKNOWN	PASS	PASS
demo_149	—	—	note_candidate	PASS	PASS	PASS	UNKNOWN	PASS	FAIL
demo_107	—	—	note_candidate	PASS	UNKNOWN	PASS	UNKNOWN	UNKNOWN	PASS
demo_114	—	—	note_candidate	UNKNOWN	PASS	UNKNOWN	PASS	UNKNOWN	PASS
demo_115	—	—	note_candidate	UNKNOWN	UNKNOWN	UNKNOWN	PASS	PASS	PASS
demo_116	—	—	note_candidate	PASS	FAIL	FAIL	PASS	PASS	FAIL
demo_132	—	—	note_candidate	FAIL	FAIL	PASS	FAIL	PASS	PASS
demo_139	—	—	note_candidate	UNKNOWN	UNKNOWN	FAIL	PASS	PASS	PASS
demo_142	—	—	note_candidate	PASS	PASS	UNKNOWN	FAIL	PASS	FAIL
demo_150	—	—	note_candidate	FAIL	FAIL	PASS	PASS	UNKNOWN	PASS
demo_103	—	—	note_candidate	UNKNOWN	PASS	FAIL	PASS	FAIL	UNKNOWN
demo_138	—	—	note_candidate	UNKNOWN	FAIL	UNKNOWN	FAIL	PASS	PASS
demo_146	—	—	note_candidate	PASS	UNKNOWN	PASS	UNKNOWN	FAIL	FAIL
demo_120	—	—	note_candidate	FAIL	UNKNOWN	FAIL	PASS	FAIL	UNKNOWN
demo_131	—	—	note_candidate	FAIL	UNKNOWN	PASS	UNKNOWN	FAIL	FAIL