Female-Specific Modifiers for Healthy Early Action in Cardiovascular Risk Trajectories
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personal training, App-based physical intervention.
- Who it may be relevant to
- Registry conditions: Perimenopausal Women, Postmenopausal Female Patients, Cardiovascular (CV) Risk. Basic parameters: 35 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Personal training
Personal training (strength and endurance, Yoga), nutrition and stress relief advices - Behavioral App-based physical intervention
FEM-HEART specific App for life-style modifications including physical exercise, relaxation and nutrition
Primary outcome measures
- Changes in HRV prior to post intervention [Time frame: 1 year intervention, 2 years follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Dervic E, Deischinger C, Haug N, Leutner M, Kautzky-Willer A, Klimek P. The Effect of Cardiovascular Comorbidities on Women Compared to Men: Longitudinal Retrospective Analysis. JMIR Cardio. 2021 Oct 4;5(2):e28015. doi: 10.2196/28015. PMID 34605767
Identifiers
NCT: NCT07703124 · FEM-HEART