Status:
COMPLETED
PROMs From GEstIC Heart Failure Patients
Lead Sponsor:
Centro Hospitalar do Porto
Collaborating Sponsors:
Promptly Health
EIT Health
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Heart failure (HF) is a chronic condition with substantial morbidity, and understanding its effects on patients' quality of life is essential. Patient-reported outcomes (PROs) are any result of a dis...
Detailed Description
PROFIC-HF will randomize 75 participants to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and 75 to complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The trial...
Eligibility Criteria
Inclusion
- Written Informed Consent (IC) signed before any study- specific procedure,
- Adult patients diagnosed with HF, undergoing treatment at GEstIC,
- Ability and willingness to understand the proposed questionnaires, per physician judgment and
- Ability and willingness to access the platform for completing the data by themselves or with the help of a caregiver (proxy)
Exclusion
- Inability to give the answers to the questions in the questionnaires,
- Moderate or severe cognitive impairment that precludes the understanding of the questions, per physician judgment,
- Malignancy or other non-cardiac condition limiting life-expectancy to \< 12 months, per physician judgment or
- Any other condition or therapy that would make the subject unsuitable to this study and would not allow participation for the full planned study period, in the judgment of the investigator.
Key Trial Info
Start Date :
December 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT06938698
Start Date
December 12 2022
End Date
March 15 2024
Last Update
April 24 2025
Active Locations (1)
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1
Centro Hospitalar Universitário do Porto
Porto, Portugal, 4099-001