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

Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03092843
Acronym
SPIRIT-HCM
Enrollment
177
Registered
2017-03-28
Start date
2017-03-20
Completion date
2023-03-30
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

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

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change in Quality of Life Change in Summary Score1 year post myectomyMild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ

Secondary

MeasureTime frameDescription
Change in Quality of Life Change in Patient Reported Outcomes1 year post myectomyQuality 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 myectomyQuality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire
Change in functional capacity post myectomy1 year post myectomyFunctional capacity will be measured by 6 minute walk

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026