Clinical trial NCT04080492: A Cardiac Disease Quality of Life Study
Official title: A Prospective Study to Assess Multi-Domain Patient-Reported Cardiac Quality of Life in Adults With Hypertrophic Cardiomyopathy, Thoracic Aortopathy, and Radiation-Induced Heart Disease: UPLIFT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Obstructive Cardiomyopathy
Thoracic Aortic Dilatation
Heart Disease Caused by Ionising Radiation
Quality of Life
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include first-time patients being seen at the Cleveland Clinic whose information will be collected in-person and remotely.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.
timeFrame: 9 months after baseline visit
measure: Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline
timeFrame: 9 months after baseline visit
measure: Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline.
timeFrame: 9 months after baseline visit
measure: Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.
timeFrame: 9 months after baseline visit
measure: Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
timeFrame: 9 months after baseline visit
measure: Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
timeFrame: 9 months after baseline visit
measure: Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
timeFrame: 9 months after baseline visit
measure: Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.
timeFrame: 9 months after baseline visit
measure: Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic.
timeFrame: Baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Milind Desai, M. D.
role: PRINCIPAL_INVESTIGATOR
References: