Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure

Completed

Conditions studied: Heart Failure

In brief

This is a prospective, observational, open study that will utilize the following tools: survey/questionnaire research, interviews, and focus groups, and secondary/archival data analysis. In addition, a subset of selected subjects will be asked to provide blood samples to examine the biologic determinants of patient health status in heart failure (HF). This will help us understand better the biomarkers or genetic factors that may cause differences in patient quality of life.

Key facts

Study ID

NCT04264845

Run by

Intermountain Health Care, Inc.

People needed

1033

Starts

2019-12-01

Expected to finish

2024-05-31

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible participants in the Provider Focus Group and Patient Interview Group:
• Male or female > 18 years of age
• Ability to understand and provide agreement to participation, which must be obtained prior to initiation of any study procedures
• Willing and able to comply with the protocol requirements and schedule of evaluations
• The Provider Focus Group must meet the following additional criteria:
• Heart failure providers, including cardiologists, cardiothoracic surgeons, physician assistants, nurse practitioners, nurses, and medical assistants.
• 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:
• 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
• Ability to complete PROs, including the KCCQ12 and PROMIS
• Ability to complete a telephone interview
• The PROs/Clinical Data Integration Group must meet the following criteria:
• Male or female > 18 years of age
• 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
• 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

You may not qualify if…

• Provider Focus Group:
• The provider is not interested or is unable to participate in the focus group
• The Principal Investigator determines that the provider is not eligible for this research study
• Patient Interview Group:
• The patient is not willing to be interviewed
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• 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
• The Principal Investigator determines that the proposed patient is not eligible for this research study
• PROs/Clinical Data Integration Group:
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• Other conditions that in the opinion of the Principal Investigator may compromise the quality of the clinical trial
• 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

Where it is running

• Intermountain Heart Institute — Murray, Utah, United States

Full record on ClinicalTrials.gov

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