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

NCT07703124 | Not Yet Recruiting

• 1 other identifier: FEM-HEART
• Study Type: interventional
• Target: 605
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes in HRV prior to post intervention

  1 year intervention, 2 years follow-up

Study Arms (2)

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

Interventions

Personal training BEHAVIORAL

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

perimenopausal women with CVD risk; postmenopausal women with CVD risk

App-based physical intervention BEHAVIORAL

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

perimenopausal women with CVD risk; postmenopausal women with CVD risk

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Cardiovascular Research: lead

Related Publications (1)

• 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 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): October 31, 2031
• Last Updated: July 21, 2026

Record last verified: 2026-07