Can patient reports predict heart failure shifts?
NCT ID NCT04264845
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study with over 1,000 participants looked at whether patient surveys and interviews can help doctors spot changes in heart failure. Researchers also collected blood samples to explore links between biology and quality of life. The goal was to see if these tools are practical and useful in routine care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors use patient feedback to better manage heart failure and spot health changes earlier.
- What could go wrong
- This is an observational study, not testing a treatment. Results may not lead to direct improvements in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,033 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All heart failure providers at the Intermountain Medical Center are potential participants in the Provider Focus Group. Patients with heart failure who are seen in the HF outpatient clinics at Intermountain Medical Center are potential participants in the Patient Interview Group or the PROs/Clinical Data Integration Group.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Eligible participants in the Provider Focus Group and Patient Interview Group: 1. Male or female \> 18 years of age 2. Ability to understand and provide agreement to participation, which must be obtained prior to initiation of any study procedures 3. Willing and able to comply with the protocol requirements and schedule of evaluations The Provider Focus Group must meet the following additional criteria: 1. Heart failure providers, including cardiologists, cardiothoracic surgeons, physician assistants, nurse practitioners, nurses, and medical assistants. 2. They are members of the University of Utah and/or Intermountain Medical Center Heart Failure Teams. The Patient Interview Group must meet the following additional criteria: 1. Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%) 2. The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah 3. Ability to complete PROs, including the KCCQ12 and PROMIS 4. Ability to complete a telephone interview The PROs/Clinical Data Integration Group must meet the following criteria: 1. Male or female \> 18 years of age 2. Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%) 3. The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah 4. No other inclusion criteria are required for this group because study-required information will be obtained from electronic medical records and will not require direct patient contact. A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, provided they meet the following criteria: * Age \> 18 * Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%) * The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah * The patient has no contraindications for blood draws Exclusion Criteria: Provider Focus Group: 1. The provider is not interested or is unable to participate in the focus group 2. The Principal Investigator determines that the provider is not eligible for this research study Patient Interview Group: 1. The patient is not willing to be interviewed 2. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study 3. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial 4. The Principal Investigator determines that the proposed patient is not eligible for this research study PROs/Clinical Data Integration Group: 1. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study 2. Other conditions that in the opinion of the Principal Investigator may compromise the quality of the clinical trial 3. The Principal Investigator determines that the proposed patient is not eligible for this research study A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, except the following: * Patients who are not interested in providing blood samples * Patients without heart failure * Patients with contraindications to blood draws
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Intermountain Heart Institute
Murray, Utah, 84143, United States
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Other studies related to the condition(s) this trial covers.
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