Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM (SPIRIT-HCM)

NeuroTherapia, Inc.

Status: Completed

Conditions: Hypertrophic Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT03092843

17-176

Details and patient eligibility

About

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

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

177 participants in 2 patient groups

No functional capacity testing

Description:

6 minute walk Quality of life Questionaire

Functional Capacity Testing

Description:

6 minute walk Quality of Life Questionnaire Metabolic stress test