Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT04080492

Conditions

Hypertrophic Obstructive Cardiomyopathy

Thoracic Aortic Dilatation

Heart Disease Caused by Ionising Radiation

Quality of Life

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

QOL Survey

Study Details

Brief summary:

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 ID

NCT04080492

Start date

Aug 26, 2019

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Hypertrophic Cardiomyopathy

Patients being seen for the first time at the Cleveland Clinic for Hypertrophic Cardiomyopathy.

Thoracic Aortic Dilatation

Patients being seen for the first time at the Cleveland Clinic for Thoracic Aortic Dilatation.

Radiation Induced Heart Disease

Patients being seen for the first time at the Cleveland Clinic for Radiation-Induced Heart Disease.

Interventions

QOL Survey

The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.

Primary outcome measure

  • Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
  • Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline [ Time Frame: 9 months after baseline visit ]
  • Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
  • Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
  • Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
  • Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
  • Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
  • Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
  • Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]

Central Contacts and Locations

Central contacts

Milind Desai, M. D.

216-445-5250desaim2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Milind Desai, MD

216 445-5250Desaim2@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-08-20.