Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM

The Cleveland Clinic177 enrolled

Overview

Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.

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.

Study Type

OBSERVATIONAL

Enrollment

177

Conditions

Hypertrophic Cardiomyopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in Quality of Life Change in Summary Score

Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ

Time frame: 1 year post myectomy

Secondary Outcomes

Change in Quality of Life Change in Patient Reported Outcomes

Quality of Life as measured by The Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaire

Time frame: 1 year post myectomy

Change in Quality of Life Change in Duke's Activity Status Index (DASI)

Quality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire

Time frame: 1 year post myectomy

Change in functional capacity post myectomy

Functional capacity will be measured by 6 minute walk

Time frame: 1 year post myectomy

Data from ClinicalTrials.gov

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