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Hypertrophic Obstructive CardiomyopathyUPLIFTNCT04080492

A Cardiac Disease Quality of Life Study

An observational study of Hypertrophic Obstructive Cardiomyopathy and Thoracic Aortic Dilatation, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
QOL Survey
How many people
380 participants
Where
1 siteUnited States
Study dates
26 Aug 2019to 1 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

Study population: The study will include first-time patients being seen at the Cleveland Clinic whose information will be collected in-person and remotely.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this 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

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.

Read the 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.

Being tested
QOL Survey
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QOL SurveyOther

    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.

Study groups in NCT04080492
Study groupRoleWhat they receive
Hypertrophic CardiomyopathyPatients being seen for the first time at the Cleveland Clinic for Hypertrophic Cardiomyopathy.
Receives: Other: QOL Survey
Thoracic Aortic DilatationPatients being seen for the first time at the Cleveland Clinic for Thoracic Aortic Dilatation.
Receives: Other: QOL Survey
Radiation Induced Heart DiseasePatients being seen for the first time at the Cleveland Clinic for Radiation-Induced Heart Disease.
Receives: Other: QOL Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.

    The global domain of the Cardiac Quality of Life Survey assesses global health. Three questions related to 1) Perceived overall quality of life, 2) \& 3) Satisfaction with overall health status and with heart health. The Perceived overall quality of life responses range from very poor =1 to very good =5. 2) \& 3) Satisfaction responses range from very dissatisfied=1 to very satisfied=5. Total global domain score ranges from 3 to 15 points. The higher the score the less impact the cardiac disease has on quality of life.

    Measured: 9 months after baseline visit

  2. Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline

    The physical domain of the Cardiac Quality of Life Survey assesses physical function. 13 questions. 1) Perception of overall physical health: responses ranging from 1=very poor to 5=very good. 2-6) Difficulty performing day-to-day physical tasks with responses ranging from 1=very easy to 5=very difficult. 7-13) Severity of heart disease symptoms affecting day-to-day physical activities: responses ranging from 1=never to 5=always. Total physical domain score ranges from 13 to 85. The higher the score the less impact the cardiac disease has on physical health.

    Measured: 9 months after baseline visit

  3. Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline.

    The emotional domain of the Cardiac Quality of Life Survey assesses emotional health. 23 questions. 1) Perception of overall emotional health: responses ranging from 1=very poor to 5=very good. 2) effect of heart disease-related physical limitations on emotional health: responses ranging from 1=always to 5=never. Eight questions asking about anxiety with responses ranging from 1=always to 5=never. Seven questions assessing depression are incorporated with responses ranging from 1=always to 5=never. 19-23) affects from a traumatic event related to their health: responses ranging from 1=always to 5=never. Total emotional domain score ranges from 23 to 115. The higher the score the less impact the cardiac disease has on emotional health.

    Measured: 9 months after baseline visit

  4. Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline.

    The social domain of the Cardiac Quality of life survey assesses social interaction and relationships. 10 questions. 1) Overall social interaction and relationships: responses ranging from 1=very poor to 5=very good. 2) Effect of heart disease-related physical limitations on social interaction: responses ranging from 1=always to 5=never. 3-10) Confidence in social interaction with friends and family: responses ranging from 1=always to 5=never. Total social domain score ranges from 10 to 50. The higher the score, the less impact the cardiac disease has on social health.

    Measured: 9 months after baseline visit

  5. Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.

    The spiritual domain of the Cardiac Quality of life survey assesses attitudes patients have surrounding their faith and health status. 4 questions. One question asks about if one's faith helps in coping with heart-related problems with responses ranging from 1=strongly disagree to 5=strongly agree. Three questions ask about feelings of anger, injustice, and turmoil related to heart disease with responses ranging from 1=strongly agree to 5=strongly disagree. Total spiritual domain score ranges from 4 to 20. The higher the score, the less impact the cardiac disease has on spiritual health.

    Measured: 9 months after baseline visit

  6. Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.

    The self-efficacy domain of the Cardiac Quality of Life survey measures self-efficacy as it relates to symptoms of heart disease. Six questions from the Cardiac Self-Efficacy Questionnaire asks about confidence in controlling symptoms, controlling illness, and maintaining daily functioning with responses ranging from 1=strongly disagree to 5=strongly agree. Total self-efficacy score ranges from 6 to 30. The higher the score, the less impact the cardiac disease has on self-efficacy.

    Measured: 9 months after baseline visit

  7. Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.

    The resilience domain of the Cardiac Quality of Life survey measures the ability to recover quickly from difficulties. 9 questions asking about adapting to change, coping with stress, overcoming obstacles, and handling unpleasant feelings with responses ranging from 1=strongly disagree to 5=strongly agree. Total resilience score ranges from 9 to 45. The higher the score, more resilient the participant is in facing problems related to cardiac disease.

    Measured: 9 months after baseline visit

  8. Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic.

    Patients with thoracic aortic aneurysm or hypertrophic cardiomyopathy were asked questions about how the heritability of their cardiac disease affected their quality of life. 3 questions asking about how heritable cardiac disease affects the health and happiness of family members with responses ranging from 1=always to 5=never. Total score ranges from 3 to 15. The higher the score, the less impact the heritability of the cardiac disease as on the quality of life of the patient.

    Measured: 9 months after baseline visit

  9. Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic.

    RIHD patients are asked about radiation therapy history, awareness of risk of RIHD, and impact on QOL. 7 questions. One question asks about time since last radiation therapy, ranging from 1= less than 5 years ago to 5=more than 30years ago. Another asks about time since RIHD diagnosis, ranging from 1=within the past week to 5=more than five years ago. One question asks about the duration of time between the symptoms of RIHD and diagnosis of RIHD with responses ranging from 1= less than 1 month to 5=more than 1 year. One question asks about the awareness of risk of RIHD before radiation therapy with responses ranging from 1=strongly disagree to 5=strongly agree. These four questions were not totaled. Three questions ask about the overall QOL before and after RIHD diagnosis and after treatment for RIHD. Responses ranged from 1=very poor to 5=very good. Total score for this section ranges from 3 to 15 with a higher score indicating RIHD had less of an impact on the overall QOL.

    Measured: Baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start26 Aug 2019
  3. Primary completion2 Sep 2022
  4. Study completion1 Sep 2026

Why it stopped: Enrollment goal not met

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080492
Sponsor's protocol ID
19-1007
Acronym
UPLIFT
Status last verified
Sep 2026
First submitted
4 Sep 2019
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertrophic Obstructive Cardiomyopathy and Thoracic Aortic Dilatation, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Enrollment goal not met). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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