This study aims to evaluate anxiety and cardiovascular outcomes in individuals with the psycho-cardio phenotype, characterized by clinically relevant anxiety symptoms with or without established cardiovascular disease (CVD). The study will be conducted as a prospective, real-world interventional study over 12 weeks.
Participants will be allocated to either a group receiving Neurofast® supplementation (2 tablets per day) or a control group receiving no additional treatment. Psychological assessments will include the Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Cardiac Anxiety Questionnaire (CAQ). Cardiovascular parameters, including heart rate, blood pressure, and electrocardiographic (ECG) measures, will also be evaluated.
The primary objective is to assess changes in anxiety symptoms and heart rate over 12 weeks. Secondary objectives include evaluation of depressive symptoms, cardiovascular parameters, and treatment adherence in a real-world clinical setting.
Age 18-70 years (both sexes)
GAD-7 ≥ 5 and/or elevated CAQ score
PHQ-9 < 20
Stable clinical status (either no cardiovascular disease or stable cardiovascular disease)
Severe chronic kidney disease (eGFR < 50 ml/min)
Severe hepatic impairment
Psychotic disorders, bipolar disorder, or acute major depression
Unstable psychiatric or pharmacological treatment (<3 months)
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Rome Tor Vergata
Collaborator