Female-Specific Modifiers for Healthy Early Action in Cardiovascular Risk Trajectories

Cardiovascular disease is the leading cause of death in women, yet risk is systematically underestimated and preventive interventions are often initiated too late. Women are disproportionately affected by obesity, diabetes, and smoking, but they also derive greater cardioprotective benefit from physical activity, reaching near-maximal protection at approximately half the exercise dose required in men. FEM-HEART targets a critical pre-clinical window by testing whether a personalized app-based intervention and a supervised face-to-face lifestyle program, both integrating tailored exercise, nutrition, and stress reduction, can improve early cardiovascular risk profiles in high-risk women during the peri- and postmenopausal transition. In this prospective randomized controlled trial embedded in routine preventive care at SVS Gesundheitszentrum, 605 women will be randomized to a digital arm, a supervised intervention arm, or an untreated control group. The study will evaluate whether digital and supervised delivery formats differ in their ability to modify early cardiovascular trajectories before overt disease onset. By targeting this modifiable pre-clinical phase, FEM-HEART shifts cardiovascular prevention from reactive care to proactive, sex-specific risk reduction and lays the foundation for scalable, woman-centered prevention strategies.

NCT Number	NCT07703124
Lead Sponsor	Ludwig Boltzmann Institute for Cardiovascular Research
Conditions	Perimenopausal Women, Postmenopausal Female Patients, Cardiovascular (CV) Risk
Enrollment	605 participants
Start Date	2027-06-01
Primary Completion	2031-05-31 (estimated)
Study Completion	2031-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-21