Study protocol for the randomized controlled TREASURE trial: timely recovery after subclinical heart failure

Objective. Heart failure (HF) significantly impacts women, with half experiencing diastolic dysfunction and preserved ejection fraction (HFpEF). Anatomically, this is paralleled by absolute (Left Ventricular Hypertrophy (LVH)) or relative car­diac hypertrophy (concentric hypertrophy, HF stage B). Pre­eclampsia (PE) is accompanied with cardiac hypertrophy, with 40% remaining after delivery. Focusing on the early HF phase, pharmacological interventions, mainly angiotensin-convert­ing enzyme (ACE) inhibitors, show promise in slowing pro­gression towards symptomatic HF in the high-risk population of women. We propose a randomized controlled trial to as­sess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women.
Materials and Methods. We will recruit women 18 years and older with asymptomatic HF and/or diastolic dysfunction, 0.5 to 30 years postpartum, from cardiovascular risk management screening at Maastricht University Medical Center+. A total of 130 women will be 1:1 randomized for perindopril or no med­ication. Outcome measures will include cardiac echocardio­graphic parameters, blood pressure, quality of life, metabolic factors, endothelial function, and novel biomarkers.
Results. The two-year study with biannual follow-ups will include advanced echocardiography, questionnaires, blood pressure measurements, and laboratory screening. Anticipat­ed results expect substantial improvement in the perindopril group, confirmed by echocardiography with a left ventricular mass index < 95 g/m2, relative wall thickness ≤ 0.43, left ven­tricular ejection fraction ≥ 55%, and maintained normal dia­stolic function.
Conclusions. This trial aims to evaluate if ACE inhibitors treatment can normalize HF stage B and/or diastolic dysfunc­tion in formerly preeclamptic women.