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NCT04080492 · The Cleveland Clinic

A Cardiac Disease Quality of Life Study

(UPLIFT)

What this study is about

A forward-looking, longitudinal, non-comparator, non-randomly assigned observational group of participants 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.

View original scientific description

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.

Interventions

OTHER

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 measures

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 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.

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

Time frame: 9 months after baseline visit

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.

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

Time frame: 9 months after baseline visit

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.

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

Time frame: 9 months after baseline visit

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.

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

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.

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

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.

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

Time frame: 9 months after baseline visit

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.

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

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.

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

Time frame: Baseline visit

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Cleveland, Ohio

Related conditions & keywords

Hypertrophic Obstructive CardiomyopathyThoracic Aortic DilatationHeart Disease Caused by Ionising RadiationQuality of Life

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Aug 20, 2025 · Source of record for eligibility and locations

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Hypertrophic Obstructive Cardiomyopathy Treatment Options in Cleveland, Ohio

If you're searching for Hypertrophic Obstructive Cardiomyopathy treatment in Cleveland, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cleveland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Hypertrophic Obstructive Cardiomyopathy. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Ohio
Now Enrolling
Up to 1200 participants
Quick Start
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Why Consider a Clinical Trial for Hypertrophic Obstructive Cardiomyopathy?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Hypertrophic Obstructive Cardiomyopathy

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Hypertrophic Obstructive Cardiomyopathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04080492. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.