Perimenopausal WomenFEM-HEARTNCT07703124
Female-Specific Modifiers for Healthy Early Action in Cardiovascular Risk Trajectories
A study testing Personal training and App-based physical intervention in people with Perimenopausal Women and Postmenopausal Female Patients, run by Ludwig Boltzmann Institute for Cardiovascular Research.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Women, Postmenopausal Female Patients, Cardiovascular (CV) Risk
- What is being tested?
- Personal training and App-based physical intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 31 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Being tested
- Personal training, App-based physical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal trainingBehavioural
Personal training (strength and endurance, Yoga), nutrition and stress relief advices
App-based physical interventionBehavioural
FEM-HEART specific App for life-style modifications including physical exercise, relaxation and nutrition
| Study group | Role | What they receive |
|---|---|---|
| perimenopausal women with CVD risk | Active comparator | Not described Receives: Behavioral: Personal training; Behavioral: App-based physical intervention |
| postmenopausal women with CVD risk | Active comparator | Not described Receives: Behavioral: Personal training; Behavioral: App-based physical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HRV prior to post intervention
Measured: 1 year intervention, 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jun 2027 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Cardiovascular Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703124
- Sponsor's protocol ID
- FEM-HEART
- Acronym
- FEM-HEART
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34605767
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female-Specific Modifiers for Healthy Early Action in Cardiovascular Risk Trajectories
- ClinicalTrials.gov ID
- NCT07703124
- Acronym / sponsor ID
- FEM-HEART / FEM-HEART
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Cardiovascular ResearchUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal trainingPersonal training (strength and endurance, Yoga), nutrition and stress relief advices | Behavioural | perimenopausal women with CVD risk, postmenopausal women with CVD risk |
| App-based physical interventionFEM-HEART specific App for life-style modifications including physical exercise, relaxation and nutrition | Behavioural | perimenopausal women with CVD risk, postmenopausal women with CVD risk |
Primary outcome
Changes in HRV prior to post intervention
Time frame: 1 year intervention, 2 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 34605767Dervic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personal training and App-based physical intervention in people with Perimenopausal Women and Postmenopausal Female Patients, run by Ludwig Boltzmann Institute for Cardiovascular Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HRV prior to post intervention (time frame: 1 year intervention, 2 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07703124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.