| Registry | NCT07703124, acronym FEM-HEART |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 605 (Estimated) |
| Sponsor | Ludwig Boltzmann Institute for Cardiovascular Research (Other) |
| Conditions | Perimenopausal Women, Postmenopausal Female Patients, Cardiovascular (CV) Risk |
| Interventions | Personal training, App-based physical intervention (Behavioral) |
| Dates | start 2027-06-01 (estimated), primary completion 2031-05-31 (estimated), completion 2031-10-31 (estimated), first posted 2026-07-14, last updated 2026-07-21 |
Related Papers Related Patents Related Grants Related Experts
All trials for Perimenopausal Women All trials for Postmenopausal Female Patients All trials of Personal training All trials of App-based physical intervention
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| perimenopausal women with CVD risk | Active comparator | Behavioral: Personal training; Behavioral: App-based physical intervention | |
| postmenopausal women with CVD risk | Active comparator | Behavioral: Personal training; Behavioral: App-based physical intervention |
Sex: Female, ages: 35 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * women aged >35 years in the perimenopausal transition * women within 5 years after menopause and and younger than 65 years * women with two of the following: (i) established cardiovascular risk factors, such as hypertension, dyslipidemia, overweight, or smoking; (ii) female-specific and hormone-related factors, such as pregnancy-associated complications or early menarche; and (iii) elevated psychosocial stress, assessed by validated questionnaires and physiological proxies. Exclusion Criteria: * high levels of physical activity * hormone replacement therapy * major comorbidities such as diabetes, moderate-to-severe kidney or liver disease, malignant tumors, musculoskeletal or neurological conditions limiting mobility, congenital heart defects, prior cardiac events, or a history of thrombosis.