# Vrouwen ondervertegenwoordigd in hartfalen-RCT's, maar mogelijk baat meer bij medicatie — meta-analyse

*geplaatst 2026-10-23 · Hartfalen · European journal of heart failure · doi 10.1093/ejhf/xuag318 · https://hartvaat.nl/2026/10/15/vrouwen-ondervertegenwoordigd-in-hartfalen-rct-s-maar-mogelijk-baat-meer-bij-med/*

Een systematische review en meta-analyse van 56 hartfalen-RCT's toont aan dat vrouwen nog steeds ondervertegenwoordigd zijn in dit onderzoek (27% bij farmacologische trials). Sex-gestratificeerde analyses suggereren echter dat vrouwen een relatief groter voordeel hebben van farmacologische interventies (RR 0,81), terwijl dit bij device-therapie minder eenduidig is. Deze bevindingen onderstrepen de noodzaak van betere representatie in toekomstig onderzoek en kunnen helpen bij het afwegen van behandelopties voor vrouwelijke hartfalenpatiënten.

## English: Sex-Based Differences in Chronic Heart Failure: a Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A systematic review and meta-analysis of 56 heart failure RCTs reveals that women remain underrepresented in clinical trials, comprising only 27% of pharmacological study populations. However, sex-stratified analyses indicate a potentially greater relative benefit from pharmacological interventions in women (RR 0.81), whereas device trial results were less consistent. These findings highlight persistent enrollment gaps and suggest that sex-specific treatment effects should be prioritized in future heart failure research and clinical decision-making.

## Abstract (original, from the publication)

BACKGROUND: Sex-based disparities in patient enrollment and treatment effects in heart failure (HF) randomized controlled trials (RCTs) have been reported. We aim to systematically analyze sex-based enrollment and treatment effect differences in HF RCTs over time. METHODS: RCTs enrolling patients with chronic HF were systematically searched on PubMed-MEDLINE. Eligible trials included pharmacological or device-based interventions with a hard primary endpoint (mortality and hospitalization) and reporting enrollment of women. Sex-specific treatment effects (HR or RR) were extracted. Meta-analyses were performed using random-effects models, and pre-specified subgroup analyses were performed. RESULTS: A total of 56 RCTs (39 drug, 17 device) were included. The pooled proportion of women enrollment was 27.0% (95%CI: 22.0% to 32.4%) in drug trials and 25.3% (95%CI: 21.0% to 29.9%) in device trials. Women were more underrepresented in HF with reduced ejection fraction (HFrEF) than in HF with preserved EF (HFpEF) trials (21.0% vs 49.6%, p < 0.001). Among drug trials reporting sex-specific effects, the pooled sex interaction for RCTs reporting HR was 0.94 (95%CI 0.89-1.01) and RR was 0.81 (95%CI 0.68-0.96), suggesting potentially greater benefit for women. No interaction was observed between HFrEF and HFpEF trials (HR: p = 0.44; RR: p = 0.95). The pooled interaction estimate on event counts was 0.90 (95%CI 0.84-0.96). For devices, the pooled sex interaction for RCTs reporting HR was 1.05 (95%CI 0.90-1.22) and RR was 0.68 (95%CI 0.50-0.93). CONCLUSION: Women remain underrepresented in HF RCTs. Sex-stratified analyses suggest a potentially greater relative benefit of drug intervention in women, which might inform future RCTs. Further studies are required to investigate the mechanisms of these differences.

Auteurs: Luca Fazzini, Luca Pascalis, Cristina Madaudo, Giordano Maria Pugliesi, Paolo Manca, Vincenzo Nuzzi, Gregorio Tersalvi, Emilia D'Elia, Christian Cadeddu Dessalvi, Roberta Montisci, Mauro Gori, Michele Senni, Antonio Cannatà

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Bron: European journal of heart failure, https://doi.org/10.1093/ejhf/xuag318. Bijgewerkt 2026-10-16T01:12:49Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.