Anxiety, Cardiovascular Diseases
Conditions
Brief summary
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.
Detailed description
Mental health and cardiovascular disease are closely interconnected, with anxiety symptoms influencing cardiovascular outcomes, quality of life, and adherence to treatment. This study focuses on individuals presenting with the psycho-cardio phenotype, defined as the coexistence of clinically relevant anxiety symptoms with or without established cardiovascular disease. This is a prospective, real-world interventional study conducted in a clinical practice setting. Participants will be followed for 12 weeks with repeated psychological and cardiovascular assessments. Eligible participants will include adults aged 18-70 years with GAD-7 ≥ 5 and/or elevated CAQ scores and stable clinical status. Participants will be allocated into two groups: one group receiving Neurofast® supplementation (2 tablets daily, one in the morning and one in the evening) and one control group receiving no additional treatment. Assessments will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks. Psychological assessments will include GAD-7 for anxiety, PHQ-9 for depressive symptoms, and CAQ for cardiac-related anxiety. Cardiovascular assessments will include electrocardiography (ECG), heart rate, and blood pressure measurements. Laboratory evaluations, including glucose, lipid profile, and kidney function, will also be performed. The primary outcome is the change in anxiety scores (GAD-7 and CAQ) and heart rate at 12 weeks. Secondary outcomes include changes in depressive symptoms (PHQ-9), cardiovascular parameters, and assessment of treatment adherence and tolerability in a real-world clinical context. The study will be conducted in accordance with the Declaration of Helsinki and has received ethics approval from the Calabria Region Ethics Committee (Ref. No. 97/20.04.2023). All participants will provide written informed consent prior to enrollment.
Interventions
DIETARY_SUPPLEMENTNeurofast® supplement
Neurofast® is a nutraceutical formulation administered orally in tablet form and evaluated for its potential effects on psychological and cardiovascular parameters in individuals with the psycho-cardio phenotype.
Sponsors
Liaquat University of Medical & Health Sciences
University of Rome Tor Vergata
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study conducted in a real-world clinical practice setting; no masking or blinding of participants, investigators, or outcome assessors is applied.
Intervention model description
Participants will be allocated to one of two parallel groups: a group receiving Neurofast® supplementation (2 tablets per day) and a control group receiving no additional treatment, with follow-up over 12 weeks in a real-world clinical setting.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Ability to provide informed consent
Exclusion criteria
* 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) * Pregnancy or breastfeeding * Known allergy or intolerance to investigational treatments (if applicable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder-7 (GAD-7) score | Baseline to Week 12 | Change in anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores range from 0 to 21, with higher scores indicating greater anxiety severity. |
| Change in Cardiac Anxiety Questionnaire (CAQ) score | Baseline to Week 12 | Change in cardiac-related anxiety measured using the Cardiac Anxiety Questionnaire (CAQ). Higher scores indicate greater cardiac-related anxiety. |
| Change in heart rate measured by standard 12-lead ECG | Baseline to Week 12 | Heart rate (beats per minute) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12. |
| Change in PR interval measured by standard 12-lead ECG | Baseline to Week 12 | PR interval (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12. |
| Change in QRS duration measured by standard 12-lead ECG | Baseline to Week 12 | QRS duration (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12. |
| Change in corrected QT interval (QTc) measured by standard 12-lead ECG | Baseline to Week 12 | Corrected QT interval (QTc, milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) score | Baseline to Week 12 | Change in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating greater depressive severity. |
| Change in blood pressure (mmHg) | Baseline to Week 12 | Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) during clinical visits. |
| Change in standard 12-lead electrocardiographic parameters | Baseline to Week 12 | Electrocardiographic parameters routinely obtained from a standard 12-lead ECG, including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc), will be assessed and compared between baseline and Week 12. |
| Treatment adherence | Up to Week 12 | Assessment of adherence to Neurofast supplementation during the study period in a real-world clinical setting. |
Countries
Italy
Outcome results
None listed