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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07703124
Acronym
FEM-HEART
Enrollment
605
Registered
2026-07-14
Start date
2027-06-01
Completion date
2031-10-31
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular (CV) Risk, Perimenopausal Women, Postmenopausal Female Patients

Brief summary

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

Personal training (strength and endurance, Yoga), nutrition and stress relief advices

BEHAVIORALApp-based physical intervention

FEM-HEART specific App for life-style modifications including physical exercise, relaxation and nutrition

Sponsors

Ludwig Boltzmann Institute for Cardiovascular Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Changes in HRV prior to post intervention1 year intervention, 2 years follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026