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

August 4, 2023 updated by: Milind Desai, The Cleveland Clinic

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-65 with an established diagnosis of obstructive hypertrophic cardiomyopathy and scheduled for septal Myectomy surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No functional capacity testing
6 minute walk Quality of life Questionaire
Functional Capacity Testing
6 minute walk Quality of Life Questionnaire Metabolic stress test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year post myectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional capacity post myectomy
Time Frame: 1 year post myectomy
Functional capacity will be measured by 6 minute walk
1 year post myectomy
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
1 year post myectomy
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
1 year post myectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Milind Desai, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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