Heart Failure, Reduced Ejection FractionEVOLUTION-HFNCT05250011
Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice
An observational study of Heart Failure, Reduced Ejection Fraction, run by AstraZeneca at 11 sites in Italy.
Trial summary
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with dapagliflozin according to the approved HFrEF indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Reduced Ejection Fraction
- What is being tested?
- Dapagliflozin
- How many people
- 252 participants
- Where
- 11 sitesItaly
- Study dates
- 19 Apr 2022to 15 Apr 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: Patients prescribed with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) according to the approved indication will be eligible for enrollment from both outpatient and inpatient settings. The decision to treat a patient with dapagliflozin must be made prior to the decision to enroll the patient. In order to help ensuring this, participants can be enrolled only if they started treatment with dapagliflozin at least 14 days before the enrollment visit, regardless of the treatment being discontinued or suspended in the time between first dapagliflozin prescription and enrollment visit. It is expected that 250 participants will be consecutively enrolled in about 11 centres (approximately 23 participants per each study site).
Who may be able to join
- Age equal or above 18 years old at the initiation of treatment with dapagliflozin
- Participant received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) in accordance with the approved local dapagliflozin product label, i.e. with an ejection fraction of 40 percent or less
- Signed and dated informed cconsent obtained prior to enrollment into the study
Who cannot join
- Participant is enrolled less than 14 days or more than 45 days following the initiation of treatment with dapagliflozin
- Prior treatment with dapagliflozin or other treatment with a medicine of the same drug class (sodium-glucose co-transporter-2 - or SGLT2 - inhibitors)
- Initiation of dapagliflozin outside of the approved local dapagliflozin product label for HFrEF
- Diagnosis of Type 1 Diabetes
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Research Site
Brescia, BS, 25123
Research Site
Catanzaro, CZ, 88100
Research Site
Florence, FI, 50100
Research Site
Foggia, FG, 71122
Research Site
Genova, GE, 16132
Research Site
Milan, MI, 20122
Research Site
Monza, MB, 20900
Research Site
Naples, 80131
Research Site
Roma, RM, 00163
Research Site
Roma, RM, 00189
Research Site
Trieste, TS, 34125
About this study
Official title: Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with dapagliflozin according to the approved HFrEF indication. The study is aimed at providing insights into real-world drug utilization and treatment patterns of dapagliflozin in the Italian HFrEF setting, as well as patient-reported outcomes including quality of life.
Read the detailed description
Heart failure (HF) is a significant burden for public health, affecting more than 63 million people worldwide and expected to increase as the population ages; in Italy, the estimated prevalence of HF is 1-3% and the incidence rate 2-5 cases per 1000 persons per year. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality and impacts on patients' quality of life (QoL). Dapagliflozin is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors, approved for the treatment of Heart Failure with reduced Ejection Fraction (HFrEF). As with all new drugs introduced into clinical practice, there is a strong scientific interest in producing evidence from observational studies regarding the use of dapagliflozin for the treatment of HFrEF in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and health-related QoL.
The overall aim of this observational study is to describe the characteristics of patients in Italy initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns (primary objectives) as well as patient-reported outcomes including quality of life (secondary objectives).
This study is part of a multicountry study programme, including similar studies that will be conducted in other countries with similar objectives. Data from each of the individual studies may be combined in a pooled analysis.
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Being tested
- Dapagliflozin
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin, prescribed as per approved indication and current medical practice. Participants will not receive any experimental disease management intervention or experimental treatment as a consequence of their participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Single-cohort | Patients initiated on dapagliflozin according to the approved indication for heart failure with reduced ejection fraction (HFrEF) and current medical practice Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics of participants
Demographic and clinical characteristics at baseline of study participants
Measured: Baseline (enrollment)
Dapagliflozin treatment pattern
Treatment discontinuation events for dapagliflozin
Measured: 12 months from prescription of dapagliflozin
Other medications treatment patterns
Treatment change events for other medications for heart failure and glucose-lowering medications
Measured: 12 months from prescription of dapagliflozin
Secondary outcomes (2)
Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Health-Related Quality of Life: assessment of heart failure symptoms and their impact in terms of physical limitation and quality of life, as captured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is scored on a scale from 0 to 100, with higher scores indicating higher quality of life.
Measured: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)
Assessment of medication adherence to heart failure treatments, as captured by the five-items version of the Medication Adherence Report Scale (MARS-5). The MARS-5 is scored on a scale from 0 to 25, with higher scores indicating better treatment compliance.
Measured: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start19 Apr 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fullcro s.r.l.
- Responsible party
- Sponsor
- Investigators
- Marco Metra, MD, Principal investigator, UOC Cardiologia, Spedali Civili di BresciaMaurizio Volterrani, MD, Principal investigator, UO Riabilitazione Cardiologica, IRCCS San Raffaele, RomaPasquale Perrone Filardi, MD, Principal investigator, UOC Cardiologia emodinamica e UTIC, Azienda Ospedaliera Universitaria "Federico II", NapoliMassimo Iacoviello, MD, Principal investigator, Unità di Cardiologia, Azienda Ospedaliero Universitaria Ospedali Riuniti, FoggiaPietro Ameri, MD, Principal investigator, UO Clinica Malattie Apparato Cardiovascolare e UTIC, IRCCS Ospedale Policlinico San Martino, GenovaAndrea Ungar, MD, Principal investigator, Geriatria UTIG, Azienda Ospedaliero Universitaria Careggi, FirenzeCiro Indolfi, MD, Principal investigator, UO Cardiologia-Emodinamica-UTIC, Azienda Ospedaliero Universitaria Mater Domini, CatanzaroMassimo Volpe, MD, Principal investigator, UOC Cardiologia, Azienda Ospedaliera Sant'Andrea, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250011
- Sponsor's protocol ID
- D1699R00030
- Acronym
- EVOLUTION-HF
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca sponsored studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin
- ClinicalTrials.gov ID
- NCT05250011
- Acronym / sponsor ID
- EVOLUTION-HF / D1699R00030
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fullcro s.r.l.
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 22 Feb 2022 (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.
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with dapagliflozin according to the approved HFrEF indication. The study is aimed at providing insights into real-world drug utilization and treatment patterns of dapagliflozin in the Italian HFrEF setting, as well as patient-reported outcomes including quality of life.
Detailed description
Heart failure (HF) is a significant burden for public health, affecting more than 63 million people worldwide and expected to increase as the population ages; in Italy, the estimated prevalence of HF is 1-3% and the incidence rate 2-5 cases per 1000 persons per year. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality and impacts on patients' quality of life (QoL). Dapagliflozin is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors, approved for the treatment of Heart Failure with reduced Ejection Fraction (HFrEF). As with all new drugs introduced into clinical practice, there is a strong scientific interest in producing evidence from observational studies regarding the use of dapagliflozin for the treatment of HFrEF in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and health-related QoL.
The overall aim of this observational study is to describe the characteristics of patients in Italy initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns (primary objectives) as well as patient-reported outcomes including quality of life (secondary objectives).
This study is part of a multicountry study programme, including similar studies that will be conducted in other countries with similar objectives. Data from each of the individual studies may be combined in a pooled analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-cohort | – | Drug: DapagliflozinPatients initiated on dapagliflozin according to the approved indication for heart failure with reduced ejection fraction (HFrEF) and current medical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) according to the approved indication will be eligible for enrollment from both outpatient and inpatient settings. The decision to treat a patient with dapagliflozin must be made prior to the decision to enroll the patient. In order to help ensuring this, participants can be enrolled only if they started treatment with dapagliflozin at least 14 days before the enrollment visit, regardless of the treatment being discontinued or suspended in the time between first dapagliflozin prescription and enrollment visit. It is expected that 250 participants will be consecutively enrolled in about 11 centres (approximately 23 participants per each study site).
Key inclusion criteria (3 listed)
- Age equal or above 18 years old at the initiation of treatment with dapagliflozin
- Participant received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) in accordance with the approved local dapagliflozin product label, i.e. with an ejection fraction of 40 percent or less
- Signed and dated informed cconsent obtained prior to enrollment into the study
Key exclusion criteria (4 listed)
- Participant is enrolled less than 14 days or more than 45 days following the initiation of treatment with dapagliflozin
- Prior treatment with dapagliflozin or other treatment with a medicine of the same drug class (sodium-glucose co-transporter-2 - or SGLT2 - inhibitors)
- Initiation of dapagliflozin outside of the approved local dapagliflozin product label for HFrEF
- Diagnosis of Type 1 Diabetes
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 |
|---|---|---|
| DapagliflozinAlso: ForxigaDapagliflozin, prescribed as per approved indication and current medical practice. Participants will not receive any experimental disease management intervention or experimental treatment as a consequence of their participation in the study. | Drug | Single-cohort |
Primary outcome
Baseline characteristics of participants
Time frame: Baseline (enrollment)
Demographic and clinical characteristics at baseline of study participants
Dapagliflozin treatment pattern
Time frame: 12 months from prescription of dapagliflozin
Treatment discontinuation events for dapagliflozin
Other medications treatment patterns
Time frame: 12 months from prescription of dapagliflozin
Treatment change events for other medications for heart failure and glucose-lowering medications
2 secondary outcomes
Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)
Time frame: Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation)
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 28 Mar 2025.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca sponsored studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Marco Metra, MD principal investigator
UOC Cardiologia, Spedali Civili di Brescia
Maurizio Volterrani, MD principal investigator
UO Riabilitazione Cardiologica, IRCCS San Raffaele, Roma
Pasquale Perrone Filardi, MD principal investigator
UOC Cardiologia emodinamica e UTIC, Azienda Ospedaliera Universitaria "Federico II", Napoli
11 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, Reduced Ejection Fraction, run by AstraZeneca at 11 sites in Italy.
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 3 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. 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?
Baseline characteristics of participants (time frame: Baseline (enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.