Skip to main content
OpenTrials
Completed

NCT Number: NCT03092843

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Quality of Life Change in Summary Score

    Time frame: 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 outcomes

  1. Change in Quality of Life Change in Patient Reported Outcomes

    Time frame: 1 year post myectomy

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

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

    Time frame: 1 year post myectomy

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

  3. Change in functional capacity post myectomy

    Time frame: 1 year post myectomy

    Functional capacity will be measured by 6 minute walk

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: SPIRIT-HCM

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2017
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.