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

Обзор

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.

Вмешательства

• Поведенческое Personal training
  Personal training (strength and endurance, Yoga), nutrition and stress relief advices
• Поведенческое App-based physical intervention
  FEM-HEART specific App for life-style modifications including physical exercise, relaxation and nutrition

Первичные конечные точки

• Changes in HRV prior to post intervention [Срок оценки: 1 year intervention, 2 years follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07703124 · FEM-HEART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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