Mindfulness training for patients with structural heart disease.
- Conditions
- English:Patients with known structural heart disease (congenital heart disease and cardiomyopathy)Dutch:Patienten bekend met een structurele hartaandoening (aangeboren hartafwijking of cardiomyopathie)
- Registration Number
- NL-OMON26153
- Lead Sponsor
- Board of Directors, Erasmus Medical Center Rotterdam.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
Adults 18 to 65 years old known to have structural heart disease, including congenital heart disease and cardiomyopathy.
Exclusion Criteria
1. Planned operation or percutaneous intervention;
2. Inability or unwillingness to give informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 6 minute walk test has been chosen as primary outcome since it is a measure of cardiac and overall physical fitness.
- Secondary Outcome Measures
Name Time Method Key secondary outcome:<br /><br>1. Quality-of-life (SF36), using the mental- and physical composite outcome scales.<br><br /><br /><br>Other secondary outcomes:<br /><br>1. Heart rate, blood pressure, resting respiratory rate (markers of cardiac fitness);<br /><br>2. NTproBNP (a biomarker for heart failure);<br /><br>3. Cumulative cortisol in 2 cm of hair taken from the scalp (cumulative measure of stress);<br /><br>4. Composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac surgery, percutaneous cardiac intervention, electrical cardioversion);<br /><br>5. Psychological well-being (Hospital Anxiety Depression questionnaire);<br /><br>6. Preference values (societal EuroQol EQ-5D-5L values, societal SF-6D values obtained from the SF-36, VAS rating scale [Philip Moons version]);<br /><br>7. Social support (perceived social support scale 12 Blumenthal PSSS12);<br /><br>8. Medical consumption of health-care use;<br /><br>9. Health care costs;<br /><br>10. Related non-health care costs (Tic-P).