A Cardiac Disease Quality of Life Study (UPLIFT)

NeuroTherapia, Inc.

Status

Enrolling

Conditions

Thoracic Aortic Dilatation

Quality of Life

Heart Disease Caused by Ionising Radiation

Hypertrophic Obstructive Cardiomyopathy

Treatments

Other: QOL Survey

Study type

Observational

Funder types

Other

Identifiers

NCT04080492

19-1007

Details and patient eligibility

About

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.

Full description

While physicians and patients may be aware of the physical limitations that result from a diagnosis of hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD) or radiation-induced heart disease (RIHD), there is little research on the impact on quality of life from the limitations imposed with these diagnosis. This study aims to address these unknowns in patients with HCM or TAD as well as radiation-induced heart disease in first-time patients at the Cleveland Clinic. Knowledge gained from this study will provide us the ability for better management of the chronic impacts of the disease by identifying potential risk factors of low quality of life or changes in quality of life over time.

This is a prospective, longitudinal, non-comparator, non-randomized survey study describing QOL outcomes for patients with HCM, TAD, or RIHD. Patients being seen for the first time at the Cleveland Clinic for cardiac disease with no previous or scheduled surgery for HCM or TAD will electronically complete a Cardiac Quality of Life Survey at 3 time points (baseline, 3 month & 9 month). The Cardiac Quality of Life Survey measures the participant's health status in five domains - global, physical, emotional, social, and spiritual - as well as self-efficacy and resilience.

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.