Hypertrophic Cardiomyopathy
Conditions
Brief summary
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.
Detailed description
The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Scheduled to undergo septal myectomy. * Established diagnosis of obstructive HCM defined as: LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg
Exclusion criteria
* Prior septal myectomy or alcohol septal ablation * Prior myocardial infarction * Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation * Uncontrolled hypertension * Angiographically documented coronary stenosis \>50%, if available at time of screening * Inability to provide informed consent * Inability to walk without assistive devices * Peripheral artery disease with claudication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Change in Summary Score | 1 year post myectomy | Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Change in Patient Reported Outcomes | 1 year post myectomy | Quality of Life as measured by The Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaire |
| Change in Quality of Life Change in Duke's Activity Status Index (DASI) | 1 year post myectomy | Quality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire |
| Change in functional capacity post myectomy | 1 year post myectomy | Functional capacity will be measured by 6 minute walk |
Countries
United States