Phenotype Characterization of Heart Failure with Preserved Ejection Fraction in Medical Device and Surgical Trials
Bibliographic record
Abstract
AIMS: Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated with advanced age, obesity, atrial fibrillation and hypertension, and medical approaches are limited. This review aims to determine the potential of medical devices or surgical interventions in treating HFpEF and to propose specific phenotypes of HFpEF. METHODS AND RESULTS: A systematic review was conducted using various clinical trial databases and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines followed by descriptive analysis and methodology quality assessment. Inclusion criteria included a medical device or surgical intervention involving HFpEF patients defined by a left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction. Twenty-four novel trials were identified involving n = 1752 participants: 17 medical device trials [3 interatrial shunt device trials (n = 1069), 1 atrial flow regulator trial (n = 41), 3 vagal nerve stimulation trials (n = 112), 1 baroreflex activation therapy trial (n = 21), 1 cardiac contractility modulator trial (n = 47), 6 cardiac resynchronization therapy trials (n = 178) and 2 functional electrical stimulation therapy trials (n = 89)] and 7 surgical intervention trials [1 renal denervation trial (n = 25), 3 greater splanchnic nerve ablation trials (n = 111), 2 catheter ablation trials (n = 55) and 1 pericardiotomy procedure trial (n = 4)]. One trial completed phase 3 trials, 20 trials completed phase 1 trials with further trials, and 5 trials completed phase 1 trials without further trials. CONCLUSIONS: Overall, 16 out of 24 trials have at least demonstrated safety and feasibility. However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit. More robust and phenotype-based clinical trials are needed to ensure evidence-based solutions are developed in HFpEF.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".