Randomized controlled trial of mindfulness training as complementary therapy in adults with structural heart disease

Completed

• Conditions: structural heart disease; 10028593; 10007510

• Registration Number: NL-OMON38306
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

Adults 18 to 65 years old known to have structural heart disease (congenital heart disease and cardiomyopathy)

Exclusion Criteria

planned operation or percutaneous intervention
inability or unwillingness to give informed consent
inability to understand Dutch, inability to read or write Dutch
no internet acess or no email or no cell phone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome:<br /><br>* exercise tolerance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary outcome:<br /><br>* quality-of-life (SF36), using the mental- and physical composite outcome<br /><br>scales<br /><br><br /><br>Other secondary outcomes:<br /><br>* heart rate (a marker of cardiac fitness)<br /><br>* NTproBNP (a biomarker for heart failure)<br /><br>* composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac<br /><br>surgery,<br /><br>percutaneous cardiac intervention, electrical cardioversion)<br /><br>* psychological well-being (anxiety and depression)<br /><br>* Social support (Blumenthal PSSS12)<br /><br>* preference values (societal EuroQol EQ-5D-5L values, and the patients values<br /><br>though the VAS rating scale)<br /><br>* health care costs<br /><br>* related non-health care costs (Tic-P)</p><br>