RECRUITING
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A Cardiac Disease Quality of Life Study
A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by hypertrophic cardiomyopathy and thoracic aortic dilatations who are not amenable to surgery, as well as those affected radiation-induced cardiac disease caused by radiation therapy.
Conditions:
🦠 Hypertrophic Obstructive Cardiomyopathy 🦠 Thoracic Aortic Dilatation 🦠 Heart Disease Caused by Ionising Radiation 🦠 Quality of Life
🗓️ Study Start (Actual) 26 August 2019
🗓️ Primary Completion (Estimated) June 2024
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 1200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients aged 18-70 at time of consent with a confirmed diagnosis of HCM, TAD, and/or RIHD being seen at CC Main Campus for a comprehensive clinical cardiac evaluation (i.e. physician, surgeon, nurse practitioner, geneticist, testing, imaging, etc) to define treatment plan for either diagnosis as per Cleveland Clinic provider.
    • * Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to complete the emailed follow-up questionnaires.

    Exclusion Criteria:

    • * Previously had surgery or plans to have surgery (full/mini sternotomy or endovascular) in the next nine months for HCM or TAD.
    • * Inability or unwillingness to comply with study requirements in the opinion of the investigator.
    • * Inability to provide informed consent.
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 4 September 2019
  • First Submitted that Met QC Criteria 4 September 2019
  • First Posted 6 September 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 August 2023
  • Last Update Posted 7 August 2023
  • Last Verified August 2023
I'm interested ...!!