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

July 19, 2026 updated by: Ludwig Boltzmann Institute for Cardiovascular Research

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

605

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year intervention, 2 years follow-up
1 year intervention, 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Cardiovascular Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 21, 2026

Last Update Submitted That Met QC Criteria

July 19, 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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