Heart FailureHFOutcomesSPNCT04806048
Feasibility of Implementation of Recommended Standards in Patients With Heart Failure
An observational study of Heart Failure, run by Fundación Pública Galega de Investigación Biomédica INIBIC at 6 sites in Spain.
Trial summary
Longitudinal pilot study among heart failure patients from six Spanish hospitals to evaluate the feasibility of establishing and maintaining for one year the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement), as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 581 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Jun 2021to 10 Oct 2022
- 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: Based on the situation at the time of inclusion,5 types of patients are defined that reflect different clinical situations and influence the necessary follow-up plan. A.Hospitalized patients: 1. A recent diagnosis (at that admission), that is, they did not previously have the diagnosis of HF 2. Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF. B.Outpatients: 1. A recent diagnosis that is in the process of titling and/or compensation 2. A previous diagnosis, that they have suffered a decompensation, well defined because they have had to go to the emergency room (and the diuretic treatment has been increased) or have been seen in the outpatient clinic for that reason 3. "Stable" patients attending a follow-up visit.A simple follow-up
Who may be able to join
- Patients aged 18 years or older.
- Diagnosed with heart failure: Clinical identification of signs and symptoms of heart failure and objective evidence of heart dysfunction.
- Acute presentation (first presentation or decompensation of already known HF, whether or not it causes hospital admission) or chronic (stable outpatients) of any etiology
- Any value of the ejection fraction.
- Give writed informed consent to participate in the study.
Who cannot join
- Patients whose first manifestation of heart failure is cardiogenic shock, in that first episode. Those patients who survived an initial episode of shock and remain in heart failure can be included once stabilized.
- Heart transplant patients
- Patients with long-lasting ventricular assist devices
- Patients with isolated right heart failure.
- Patients with onset of heart failure and whose cause can be corrected immediately (eg, acute ischemia).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitario de A Coruña
A Coruña, 15006
Hospital Universitario Basurto
Bilbao, Vizcaya, 48013
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: Feasibility of the Use in Spanish Hospitals of Recommended Standards to Measure Results in Patients With Heart Failure (HF-Outcomes-Spain)
Longitudinal pilot study among heart failure patients from six Spanish hospitals to evaluate the feasibility of establishing and maintaining for one year the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement), as well as identifying factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information.
Read the detailed description
- MAIN GOAL To evaluate through a pilot study the viability of establishing and maintaining for one year in selected Spanish centers the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement). (International Consortium for Health Outcomes Measurement).
- SPECIFIC GOALS To identify factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information To estimate the workload necessary to implement this set of variables within everyday clinical practice.
- STUDY DESIGN Observational pilot study with prospective follow-up with data collection at 30 days, 6 months and 1 year.
Due to the defined objective, the methods used are, to a large extent, those proposed by ICHOM, except in those sections that may be slightly modified to adapt to the local situation.
3.1. Selection of centers and patients Six centers with experience and adequate organization (heart failure unit) and with a sufficient size have been selected to guarantee the recruitment of patients in a short period of time (around three weeks). The main justification was to seek, within the usual clinical practice, centers where, due to the organization and interest in heart failure, the chances of success of this initiative were greater.
100 consecutive patients with a diagnosis of heart failure who meet inclusion criteria and with no exclusion criteria will be selected in each center.
3.2. Sample size considerations For the main outcome, success is considered if the proportion of patients followed is ≥ 70%. A random sample of 588 individuals is sufficient to estimate, with 95% confidence and a precision of +/- 3.5 percentage units, a population percentage that is expected to be around 75%. Six Spanish centers will participate and a recruitment target of 100 consecutive patients is set, for a total of 600 patients in the study. In addition, these sizes in each center offer, accepting an alpha risk of 0.05, a power greater than 80% to detect statistically significant differences between two centers, assuming that a follow-up of 75% of patients is achieved in one and 55% in the other.
3.3. Follow-up From the baseline or inclusion visit and afterwards, in newly diagnosed patients or in those recruited in an acute situation, follow-up visits at 30 days, 6 months and 1 year [Hospitalized patients (1. A recent diagnosis, that is, they did not previously have the diagnosis of HF and 2.Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF) and Outpatients (1. A recent diagnosis that is in the process of titration and/or compensation and 2.A previous diagnosis, that they have suffered a decompensation, either defined because they have had to go to the emergency room or have been seen in the outpatient clinic for that reason)].
In patients who were included in a stable situation, the 30-day visit will not be carried out (Outpatients: "Stable" patients attending a follow-up visit. A simple follow-up) since doing so would unjustifiably complicate the follow-up, giving more work and discomfort to patients and health professionals. The outcomes reported by the patient (PROMs) in the visits every six months may be collected by telephone contact if the doctor, due to the stable situation of the patient, does not consider the face-to-face visit necessary. Information will be collected at in the case of hospital admissions during follow-up, these admissions also set the "counter to zero" with regard to time for the following visits (30 days, six months…).
- DATA COLLECTION AND MANAGEMENT A data entry application will be enabled that will include filters to detect inconsistencies and anomalous data and alarms for patient monitoring. The data will be anonymized for all the people involved in the study except for the person in charge in each center, who will be able to identify their patients to enable follow-up.
- PLAN FOR DATA ANALYSIS Two data analyses are planned, one that includes the information from the baseline visit and the 30-day visit (in patients for whom it is indicated in the protocol) and the final one with all the information collected. In both cases, a global analysis and a comparison between centers (benchmarking) will be carried out.
In line with the main objective of this pilot study, the main variables are the proportion of patients who remain in follow-up, the proportion of patients in whom follow-up is carried out, in terms of time, as planned, and the proportion of missing data in each one of the defined outcomes.
The pilot's success criteria will be a follow-up> 70%, a proportion of missing data in the outcomes <10%.
- Conditions
- Heart Failure
- Keywords
- Outcome, Heart-Failure, Standard of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients and outpatients | There may be different types of patients with differing follow-up plan but all will bie considered one group regarding on whether they receive their recommended follow-up plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients in follow-up
Proportion of patients who receive their recommended follow-up plan
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jun 2021
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Galega de Investigación Biomédica INIBIC
- Sponsor type
- University, hospital or other
- Collaborators
- ODDS , S.L., Vifor Pharma España, S.L.
- Responsible party
- Principal investigator, Marisa Crespo Leiro, Fundación Pública Galega de Investigación Biomédica INIBIC
- Investigators
- María G Crespo Leiro, MD, Principal investigator, Complejo Hospitalario Universitario de A Coruña (CHUAC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806048
- Sponsor's protocol ID
- HF-Outcomes-Spain
- Acronym
- HFOutcomesSP
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.
PubMed 32483830Anguita Sanchez M, Crespo Leiro MG, de Teresa Galvan E, Jimenez Navarro M, Alonso-Pulpon L, Muniz Garcia J; PRICE Study Investigators. Prevalence of heart failure in the Spanish general population aged over 45 years. The PRICE Study. Rev Esp Cardiol. 2008 Oct;61(10):1041-9. doi: 10.1016/s1885-5857(09)60007-4.
PubMed 18817680Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
PubMed 27207191Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
PubMed 24491689Anguita Sanchez M, Lambert Rodriguez JL, Bover Freire R, Comin Colet J, Crespo Leiro MG, Gonzalez Vilchez F, Manito Lorite N, Segovia Cubero J, Ruiz Mateas F, Elola Somoza FJ, Iniguez Romo A. Classification and Quality Standards of Heart Failure Units: Scientific Consensus of the Spanish Society of Cardiology. Rev Esp Cardiol (Engl Ed). 2016 Oct;69(10):940-950. doi: 10.1016/j.rec.2016.06.006. Epub 2016 Aug 27. English, Spanish.
PubMed 27576081McDonagh TA, Blue L, Clark AL, Dahlstrom U, Ekman I, Lainscak M, McDonald K, Ryder M, Stromberg A, Jaarsma T; European Society of Cardiology Heart Failure Association Committee on Patient Care. European Society of Cardiology Heart Failure Association Standards for delivering heart failure care. Eur J Heart Fail. 2011 Mar;13(3):235-41. doi: 10.1093/eurjhf/hfq221. Epub 2010 Dec 15.
PubMed 21159794Burns 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 31838032McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.
PubMed 25991011
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Use in Spanish Hospitals of Recommended Standards to Measure Results in Patients With Heart Failure (HF-Outcomes-Spain)
- ClinicalTrials.gov ID
- NCT04806048
- Acronym / sponsor ID
- HFOutcomesSP / HF-Outcomes-Spain
- Conditions
- Heart Failure
- Keywords
- Outcome, Heart-Failure, Standard of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Fundación Pública Galega de Investigación Biomédica INIBICUniversity, hospital or other
- Collaborators
- ODDS , S.L., Vifor Pharma España, S.L.
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 19 Mar 2021 (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.
Longitudinal pilot study among heart failure patients from six Spanish hospitals to evaluate the feasibility of establishing and maintaining for one year the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement), as well as identifying factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information.
Detailed description
- MAIN GOAL To evaluate through a pilot study the viability of establishing and maintaining for one year in selected Spanish centers the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement). (International Consortium for Health Outcomes Measurement).
- SPECIFIC GOALS To identify factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information To estimate the workload necessary to implement this set of variables within everyday clinical practice.
- STUDY DESIGN Observational pilot study with prospective follow-up with data collection at 30 days, 6 months and 1 year.
Due to the defined objective, the methods used are, to a large extent, those proposed by ICHOM, except in those sections that may be slightly modified to adapt to the local situation.
3.1. Selection of centers and patients Six centers with experience and adequate organization (heart failure unit) and with a sufficient size have been selected to guarantee the recruitment of patients in a short period of time (around three weeks). The main justification was to seek, within the usual clinical practice, centers where, due to the organization and interest in heart failure, the chances of success of this initiative were greater.
100 consecutive patients with a diagnosis of heart failure who meet inclusion criteria and with no exclusion criteria will be selected in each center.
3.2. Sample size considerations For the main outcome, success is considered if the proportion of patients followed is ≥ 70%. A random sample of 588 individuals is sufficient to estimate, with 95% confidence and a precision of +/- 3.5 percentage units, a population percentage that is expected to be around 75%. Six Spanish centers will participate and a recruitment target of 100 consecutive patients is set, for a total of 600 patients in the study. In addition, these sizes in each center offer, accepting an alpha risk of 0.05, a power greater than 80% to detect statistically significant differences between two centers, assuming that a follow-up of 75% of patients is achieved in one and 55% in the other.
3.3. Follow-up From the baseline or inclusion visit and afterwards, in newly diagnosed patients or in those recruited in an acute situation, follow-up visits at 30 days, 6 months and 1 year [Hospitalized patients (1. A recent diagnosis, that is, they did not previously have the diagnosis of HF and 2.Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF) and Outpatients (1. A recent diagnosis that is in the process of titration and/or compensation and 2.A previous diagnosis, that they have suffered a decompensation, either defined because they have had to go to the emergency room or have been seen in the outpatient clinic for that reason)].
In patients who were included in a stable situation, the 30-day visit will not be carried out (Outpatients: "Stable" patients attending a follow-up visit. A simple follow-up) since doing so would unjustifiably complicate the follow-up, giving more work and discomfort to patients and health professionals. The outcomes reported by the patient (PROMs) in the visits every six months may be collected by telephone contact if the doctor, due to the stable situation of the patient, does not consider the face-to-face visit necessary. Information will be collected at in the case of hospital admissions during follow-up, these admissions also set the "counter to zero" with regard to time for the following visits (30 days, six months…).
- DATA COLLECTION AND MANAGEMENT A data entry application will be enabled that will include filters to detect inconsistencies and anomalous data and alarms for patient monitoring. The data will be anonymized for all the people involved in the study except for the person in charge in each center, who will be able to identify their patients to enable follow-up.
- PLAN FOR DATA ANALYSIS Two data analyses are planned, one that includes the information from the baseline visit and the 30-day visit (in patients for whom it is indicated in the protocol) and the final one with all the information collected. In both cases, a global analysis and a comparison between centers (benchmarking) will be carried out.
In line with the main objective of this pilot study, the main variables are the proportion of patients who remain in follow-up, the proportion of patients in whom follow-up is carried out, in terms of time, as planned, and the proportion of missing data in each one of the defined outcomes.
The pilot's success criteria will be a follow-up> 70%, a proportion of missing data in the outcomes <10%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients and outpatients | – | –There may be different types of patients with differing follow-up plan but all will bie considered one group regarding on whether they receive their recommended follow-up plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on the situation at the time of inclusion,5 types of patients are defined that reflect different clinical situations and influence the necessary follow-up plan. A.Hospitalized patients: 1. A recent diagnosis (at that admission), that is, they did not previously have the diagnosis of HF 2. Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF. B.Outpatients: 1. A recent diagnosis that is in the process of titling and/or compensation 2. A previous diagnosis, that they have suffered a decompensation, well defined because they have had to go to the emergency room (and the diuretic treatment has been increased) or have been seen in the outpatient clinic for that reason 3. "Stable" patients attending a follow-up visit.A simple follow-up
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Diagnosed with heart failure: Clinical identification of signs and symptoms of heart failure and objective evidence of heart dysfunction.
- Acute presentation (first presentation or decompensation of already known HF, whether or not it causes hospital admission) or chronic (stable outpatients) of any etiology
- Any value of the ejection fraction.
- Give writed informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Patients whose first manifestation of heart failure is cardiogenic shock, in that first episode. Those patients who survived an initial episode of shock and remain in heart failure can be included once stabilized.
- Heart transplant patients
- Patients with long-lasting ventricular assist devices
- Patients with isolated right heart failure.
- Patients with onset of heart failure and whose cause can be corrected immediately (eg, acute ischemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients in follow-up
Time frame: Up to 1 year
Proportion of patients who receive their recommended follow-up plan
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 3 Apr 2024.
- Background: PubMed 32483830Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.
- Background: PubMed 18817680Anguita Sanchez M, Crespo Leiro MG, de Teresa Galvan E, Jimenez Navarro M, Alonso-Pulpon L, Muniz Garcia J; PRICE Study Investigators. Prevalence of heart failure in the Spanish general population aged over 45 years. The PRICE Study. Rev Esp Cardiol. 2008 Oct;61(10):1041-9. doi: 10.1016/s1885-5857(09)60007-4.
- Background: PubMed 27207191Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
- Background: PubMed 24491689Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
- Background: PubMed 27576081Anguita Sanchez M, Lambert Rodriguez JL, Bover Freire R, Comin Colet J, Crespo Leiro MG, Gonzalez Vilchez F, Manito Lorite N, Segovia Cubero J, Ruiz Mateas F, Elola Somoza FJ, Iniguez Romo A. Classification and Quality Standards of Heart Failure Units: Scientific Consensus of the Spanish Society of Cardiology. Rev Esp Cardiol (Engl Ed). 2016 Oct;69(10):940-950. doi: 10.1016/j.rec.2016.06.006. Epub 2016 Aug 27. English, Spanish.
- Background: PubMed 21159794McDonagh TA, Blue L, Clark AL, Dahlstrom U, Ekman I, Lainscak M, McDonald K, Ryder M, Stromberg A, Jaarsma T; European Society of Cardiology Heart Failure Association Committee on Patient Care. European Society of Cardiology Heart Failure Association Standards for delivering heart failure care. Eur J Heart Fail. 2011 Mar;13(3):235-41. doi: 10.1093/eurjhf/hfq221. Epub 2010 Dec 15.
- 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.
- Background: PubMed 25991011McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.
- Individual participant dataSharing planned: No
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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.
María G Crespo Leiro, MD principal investigator
Complejo Hospitalario Universitario de A Coruña (CHUAC)
6 sites 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 Fundación Pública Galega de Investigación Biomédica INIBIC at 6 sites in Spain.
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 5 inclusion and 5 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
Patients in follow-up (time frame: Up to 1 year). 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 NCT04806048, which also lists 8 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 3 Apr 2024.