Female-Specific Modifiers for Healthy Early Action in Cardiovascular Risk Trajectories (FEM-HEART)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular (CV) Risk; Perimenopausal Women; Postmenopausal Female Patients
• Intervention / Treatment: Behavioral: Personal training; Behavioral: App-based physical intervention

• Study Type: Interventional
• Enrollment (Estimated): 605
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:Eligible participants will be women aged >35 years in the perimenopausal transition or within 5 years after menopause and 35 years and in the perimenopausal transition (A) or within five years after menopause and younger than 65 years (B). In addition, all must meet at least two of three predefined risk profiles: (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: include high levels of physical activity, hormone replacement therapy, and 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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: perimenopausal women with CVD risk	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
Active Comparator: postmenopausal women with CVD risk	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HRV prior to post intervention	1 year intervention, 2 years follow-up

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Cardiovascular Research

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): October 31, 2031

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FEM-HEART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No