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

NCT07703124 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2026-07-21

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Ludwig Boltzmann Institute for Cardiovascular Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-06-01
Primary Completion
2031-05-31
Completion
2031-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703124 on ClinicalTrials.gov