Trial · NCT05350202
Emp-Activity: Empagliflozin Functional Capacity
NCT05350202, Completed, Boehringer Ingelheim; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Emp-Activity: Empagliflozin Functional Capacity. Trials, record NCT05350202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05350202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Emp-Activity: Empagliflozin Functional Capacity
- NCT number
- NCT05350202
- Status
- Completed
- Enrollment
- 3,431 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Heart Failure
- Interventions
- Empagliflozin
- First posted
- 2022-04-28
- Last updated
- 2025-08-26
- Results first posted
- 2025-08-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | At baseline and at week 24. | Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \[Week 24\] - \[Baseline\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status. |
| Secondary | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | At baseline and at Week 24. | This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. |
| Secondary | Number of Participants With Comorbidities | At baseline. | Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code. |
| Secondary | Number of Participants With Concomitant Heart-failure (HF) Related Medication | At baseline. | Number of patients who took concomitant HF-related medication. |
| Secondary | Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline | Up to 6 months prior to baseline visit. | Number of patients hospitalized at least one time due to heart failure (HF). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | At baseline and at week 24. | Primary endpoint set (PES): All patients, who received at least one dose of empagliflozin for HF and have filled in KCCQ at baseline and week 24. | Units on a scale | MEAN |
| SECONDARY | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | At baseline and at Week 24. | Safety set (SAF): All patients of FAS who received empagliflozin at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Comorbidities | At baseline. | FAS: All registered patients who gave informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Concomitant Heart-failure (HF) Related Medication | At baseline. | FAS: All registered patients who gave informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline | Up to 6 months prior to baseline visit. | FAS: All registered patients who gave informed consent. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group113
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | Empagliflozin-treated Patients | CSS | 14.66 | Standard Deviation 18.44 | Units on a scale |
| Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | Empagliflozin-treated Patients | TSS | 17.61 | Standard Deviation 21.04 | Units on a scale |
| Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | Empagliflozin-treated Patients | OSS | 16.47 | Standard Deviation 18.86 | Units on a scale |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Week 24 Class I | 337 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Week 24 Class II | 1388 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Week 24 Class III | 54 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Week 24 Class IV | 0 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Unknown | 5 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / Missing | 184 | Participants | |
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Empagliflozin-treated Patients | Baseline Class II / No Week 24 visit | 13 | Participants |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Visit 1 - Baseline | STARTED | Empagliflozin-treated Patients | 3,327 | |
| Visit 1 - Baseline | STARTED | Non-SGLT2i-treated Patients | 104 | |
| Visit 1 - Baseline | Full Analysis Set (FAS) | Empagliflozin-treated Patients | 3,320 | |
| Visit 1 - Baseline | Full Analysis Set (FAS) | Non-SGLT2i-treated Patients | 104 | |
| Visit 1 - Baseline | Treated | Empagliflozin-treated Patients | 3,309 | |
| Visit 1 - Baseline | Treated | Non-SGLT2i-treated Patients | 104 | |
| Visit 1 - Baseline | COMPLETED | Empagliflozin-treated Patients | 3,309 | |
| Visit 1 - Baseline | COMPLETED | Non-SGLT2i-treated Patients | 104 | |
| Visit 1 - Baseline | NOT COMPLETED | Empagliflozin-treated Patients | 18 | |
| Visit 1 - Baseline | NOT COMPLETED | Non-SGLT2i-treated Patients | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Empagliflozin-treated Patients | 17 | 3,309 | |
| serious | Cardiac failure | Cardiac disorders | Empagliflozin-treated Patients | 14 | 3,309 | |
| serious | Cardiac arrest | Cardiac disorders | Empagliflozin-treated Patients | 3 | 3,309 | |
| serious | Cardiogenic shock | Cardiac disorders | Empagliflozin-treated Patients | 3 | 3,309 | |
| serious | Sudden cardiac death | General disorders | Empagliflozin-treated Patients | 3 | 3,309 | |
| serious | Acute kidney injury | Renal and urinary disorders | Empagliflozin-treated Patients | 2 | 3,309 | |
| serious | Acute myocardial infarction | Cardiac disorders | Empagliflozin-treated Patients | 2 | 3,309 | |
| serious | Atrial fibrillation | Cardiac disorders | Empagliflozin-treated Patients | 2 | 3,309 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Empagliflozin-treated Patients | 2 | 3,309 | |
| serious | Cerebrovascular accident | Nervous system disorders | Empagliflozin-treated Patients | 2 | 3,309 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Empagliflozin-treated Patients | 46 | 3,309 |
| Total, other adverse events | Empagliflozin-treated Patients | 0 | 3,309 |
| Total, serious adverse events | Empagliflozin-treated Patients | 74 | 3,309 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Empagliflozin-treated Patients vs Non-SGLT2i-treated Patients: Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05350202
GET https://conductscience.org/api/trials/v1/NCT05350202/results?page=2