Heart FailurePROFIC-HFNCT06938698
PROMs From GEstIC Heart Failure Patients
An observational study of Heart Failure, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial 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 disease or treatment that comes directly from the patient, without any interpretation from clinicians, using standardized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PROM collection
- How many people
- 155 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Dec 2022to 15 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with Heart Failure, undergoing treatment at GEstIC. Eligible patients will be identified by GEstIC physicians/investigators in HF hospital appointments.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study
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 disease or treatment that comes directly from the patient, without any interpretation from clinicians, using standardized scientifically-validated medical questionnaires, PROMs. Patient-reported outcome measures (PROMs) are the tools used to capture PRO information usually in the form of questionnaires.
Read more
The PROMs from GEstIC Heart Failure Patients (PROFIC-HF) study aims to assess the feasibility of digitally recording Patient-Reported Outcome Measures (PROMs) at home in real-world patients enrolled in a multidisciplinary heart failure clinic. Two HF-specific PROMs - Kansas City Questionnaire (KCCQ-12) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) - and a 2 PROMs for anxiety and depression assessment - Patient Health Questionnaire -2 (PHQ-2) and The Hospital Anxiety and Depression Scale (HADS) will be collected remotely using a digital platform that can be accessed online using a smartphone or a computer.
This study will also evaluate the correlation between quality of life changes (measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire) and changes in clinical reported outcomes: assess the quality of life of real world HFpatients followed in a multidisciplinary heart failure clinic and quantify the impact of hospitalization events on patients' quality of life.
Read the 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 will pilot the use of the digital PROMs system, collected from the consultation waiting room and/or with the patient at home.
PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up program already in use by GEstIC.
- Conditions
- Heart Failure
- Being tested
- PROM collection
- Keywords
- Heart Failure, Patient-Reported Outcome Measures, Clinical Outcomes, Quality of Life, Telemedicine, Feasibility Studies
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROM collectionOther
PROM collection using a digital health web application. PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up protocol already in use by GEstIC. Half the participants will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the other half will complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure patients | Patients of the GEstIC Heart Failure clinic will use a digital PROMs system, collecting information on the consultation waiting room and/or with the patient at home using a web based application that runs on the smartphone or computer with internet connection. Receives: Other: PROM collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life as measured by KCCQ-12 versus MLHFQ
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Minnesota living with Heart Failure (MLHFQ) are a quality of life (QoL) questionnaires specific for heart failure. Patients will be randomized to answer to only one of the questionnaires.
KCCQ consists of 12 questions specific to HF and appraises QoL over the last two weeks; scores range from 0 to 100, where higher score means better QoL. The MLHFQ consists of 21 questions and appraises QoL over the previous month. Questions are answered using a Likert scale ranging from 0-5; score range is 0-105, with higher score representing a poorer QoL.
Measured: Measurement at 0, 1 and 6 months after informed consent.
Secondary outcomes (3)
Correlation between quality of life changes, measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire (MLHFQ), and changes in clinical reported outcomes.
KCCQ-12 and MLHFQ are HF-specific quality of life questionnaires. Patients will either answer to only one of the questionnaires.
Measured: Measurement at 0, 1 and 6 months after informed consent.
Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.
Measurement of quality of life after HF hospitalizations, using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota living with Heart Failure (MLHFQ). Patients will be randomized to answer to only one of the questionnaires.
KCCQ consists of 12 questions specific to HF and appraises QoL over the two weeks; scores range from 0 to 100, where higher score means better QoL. The MLHFQ consists of 21 questions and appraises QoL over the previous month. Questions are answered using a Likert scale ranging from 0-5; score range is 0-105, with higher score representing a poorer QoL..
Measured: Measurement at 0, 1 and 6 months from discharge.
Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)
HADS will be used to assess anxiety and depression. HADS is a 14-item scale, in which all items are rated on a 4-point Likert scale, and scores are 19 computed by summing the scores of each subscale, for anxiety or depression. Scores range from 0 to 20, where higher scores indicate more anxiety or depression symptoms.
Measured: Measurement at 0, 1 and 6 months after informed consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start12 Dec 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Promptly Health, EIT Health
- Responsible party
- Principal investigator, Irene Marques, Centro Hospitalar do Porto
- Investigators
- Irene Marques, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938698
- Sponsor's protocol ID
- 2020.032
- Acronym
- PROFIC-HF
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.
PubMed 31838032Marques, I., Gomes, C., Viamonte, S., Ferreira, G. e Mendonça, C. 2017. Clínica Multidisciplinar de Insuficiência Cardíaca: Como Implementar. Medicina Interna. 24, 4 (Dez. 2017), 308-317. DOI:https://doi.org/10.24950/rspmi/R58/17/2017.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study
- ClinicalTrials.gov ID
- NCT06938698
- Acronym / sponsor ID
- PROFIC-HF / 2020.032
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Patient-Reported Outcome Measures, Clinical Outcomes, Quality of Life, Telemedicine, Feasibility Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Collaborators
- Promptly Health, EIT Health
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 disease or treatment that comes directly from the patient, without any interpretation from clinicians, using standardized scientifically-validated medical questionnaires, PROMs. Patient-reported outcome measures (PROMs) are the tools used to capture PRO information usually in the form of questionnaires.
The PROMs from GEstIC Heart Failure Patients (PROFIC-HF) study aims to assess the feasibility of digitally recording Patient-Reported Outcome Measures (PROMs) at home in real-world patients enrolled in a multidisciplinary heart failure clinic. Two HF-specific PROMs - Kansas City Questionnaire (KCCQ-12) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) - and a 2 PROMs for anxiety and depression assessment - Patient Health Questionnaire -2 (PHQ-2) and The Hospital Anxiety and Depression Scale (HADS) will be collected remotely using a digital platform that can be accessed online using a smartphone or a computer.
This study will also evaluate the correlation between quality of life changes (measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire) and changes in clinical reported outcomes: assess the quality of life of real world HFpatients followed in a multidisciplinary heart failure clinic and quantify the impact of hospitalization events on patients' quality of life.
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 will pilot the use of the digital PROMs system, collected from the consultation waiting room and/or with the patient at home.
PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up program already in use by GEstIC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure patients | – | Other: PROM collectionPatients of the GEstIC Heart Failure clinic will use a digital PROMs system, collecting information on the consultation waiting room and/or with the patient at home using a web based application that runs on the smartphone or computer with internet connection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Heart Failure, undergoing treatment at GEstIC. Eligible patients will be identified by GEstIC physicians/investigators in HF hospital appointments.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROM collectionPROM collection using a digital health web application. PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up protocol already in use by GEstIC. Half the participants will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the other half will complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ). | Other | Heart Failure patients |
Primary outcome
Health-related quality of life as measured by KCCQ-12 versus MLHFQ
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Minnesota living with Heart Failure (MLHFQ) are a quality of life (QoL) questionnaires specific for heart failure. Patients will be randomized to answer to only one of the questionnaires. KCCQ consists of 12 questions specific to HF and appraises QoL over the last two weeks; scores range from 0 to 100, where higher score means better QoL. The MLHFQ consists of 21 questions and appraises QoL over the previous month. Questions are answered using a Likert scale ranging from 0-5; score range is 0-105, with higher score representing a poorer QoL.
3 secondary outcomes
Correlation between quality of life changes, measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire (MLHFQ), and changes in clinical reported outcomes.
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.
Time frame: Measurement at 0, 1 and 6 months from discharge.
Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 31838032Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.
- BackgroundMarques, I., Gomes, C., Viamonte, S., Ferreira, G. e Mendonça, C. 2017. Clínica Multidisciplinar de Insuficiência Cardíaca: Como Implementar. Medicina Interna. 24, 4 (Dez. 2017), 308-317. DOI:https://doi.org/10.24950/rspmi/R58/17/2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Marques, MD principal investigator
Centro Hospitalar do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centro Hospitalar do Porto at 1 site in Portugal.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Apr 2025. 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 Portugal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health-related quality of life as measured by KCCQ-12 versus MLHFQ (time frame: Measurement at 0, 1 and 6 months after informed consent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938698, which also lists 2 linked publications.
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 24 Apr 2025.