Chronic Heart FailurePhase 3The CANA -AHFNCT05364190
Canagliflozin in Patients With Acute Decompansted Heart Failure
A Phase 3 study testing Canagliflozin and Empagliflozin in people with Chronic Heart Failure and Acute Heart Failure, run by October 6 University at 1 site in Egypt.
Trial summary
The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Heart Failure, Acute Heart Failure, Diabetes Mellitus
- What is being tested?
- Canagliflozin and Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jun 2022to 1 Mar 2024
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Randomized within 24 of presentation during hospital admission for hypervolemic ADHF with evidence of congestion defined by the presence of any of the following signs or symptoms:
- Peripheral edema Ascites Jugular venous pressure > 10 mmHg Orthopnea Paroxysmal nocturnal dyspnea 2.5 kg weight gain Signs of congestion on chest X-ray or lung ultrasound If pulmonary artery catheterization is available pulmonary capillary wedge pressure > 19 mmHg plus a systemic physical examination finding of hypervolemia.
- Planned use of intravenous (IV) loop diuretic therapy during the current hospitalization Estimated glomerular filtration rate (e-GFR) > 30 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Who cannot join
- Type 1 diabetes Serum glucose < 80 mg/dL Systolic blood pressure < 90 mmHg Requirement of IV inotropic therapy History of hypersensitivity to any SGLT-2 inhibitors Already receiving therapy with an SGLT2 inhibitor Women who are pregnant or breastfeeding Severe anemia (Hemoglobin < 7.5 g/dL)(24) Severe uncorrected aortic or mitral stenosis Inability to perform standing weights or measure urine output accurately Signs of ketoacidosis and/or hyperosmolar hyperglycaemic syndrome (pH >7.3 and glucose > 250 mg/dL and HCO3 > 18 mmol/L) in diabetic patients at the time of inclusion to the study.
- The use of other diuretic therapies including; ≥100 mg/day spironolactone doses, ≥ 100 mg/day eplerenone, metolazone, hydrochlorothiazide, or other thiazides, systemic acetazolamide for the indication of diuretics, triamterene, or amiloride therapy.
- The use of other medications possessing natriuretic effect as nesiritide, or arginine vasopressin antagonists.
- Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 18 kg. Severe hepatic impairment (Child-Pugh class C). Patients on hemodialysis Acute myocardial infarction with symptoms of acute ischemia or changes on electrocardiogram
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Early Initiation of Canagliflozin in Patients With Acute Decompansted Heart Failure
The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period.
Read the detailed description
The study will focus on the role of adding canagliflozin to I.V loop diuretic therapy early in unstable hospitalized acute heart failure patients regardless of diabetic state, patients who will be included in the study will continue on canagliflozin for 3 months after hospital discharge to evaluate the incidence of re-hospitalization, mortality rate and other benefits related to HF symptoms will be investigated.
- Being tested
- Canagliflozin, Empagliflozin
- Keywords
- Canagliflozin, Hospitalized heart failure patients, I.V loop diuretic, NT-proBNP
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Canagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.
EmpagliflozinDrug
Empagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.
| Study group | Role | What they receive |
|---|---|---|
| Group A(Intervention group) | Experimental | patients will receive 100 mg canagliflozin initiated within 24 hours from patients hospital admission due to signs of hypervolemic state. All patients also will be prescribed the conventional diuretic therapy and other medications such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI) and mineralocorticoid receptor antagonists (MRAs). Canagliflozin will be continued for 90 days after hospital discharge Receives: Drug: Canagliflozin |
| Group B | Active comparator | patients will receive 10 mg Empagliflozin initiated within 24 hours from patients hospital admission due to signs of a hypervolemic state.All patients also will be prescribed conventional diuretic therapy and other medications including ACEIs, ARBs, beta-blockers, ARNI, and MRAs.Empagliflozin will be continued for 90 days after hospital discharge Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative mean of daily diuresis
which is define as total urine output in 24 hours during the hospitalization period.
Measured: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier
Secondary outcomes (16)
Measuring diuretic response
which is the cumulative change in weight (kg) from enrollment until discharge adjusted for cumulative diuretic dose in IV furosemide or equivalents
Measured: Baseline to hospital discharge, an average of 5-6 days
The change in the level of NT-pro BNP
The change in the level of NT-pro BNP between the hospital admission day and the day of discharge.
Measured: Baseline to hospital discharge, an average of 5-6 days
Presence of symptoms of congestion and dyspnea at discharge
measured via the change in visual analogue scale (VAS) dyspnea score between enrollment day and the discharge day. the score goes between 0-10 where 0 = no breathlessness to 10 = worst breathlessness possible.
Measured: Baseline to hospital discharge, an average of 5-6 days.
Intensive care unit (ICU) length of stay
measured as days from admission to ICU to discharge.
Measured: Baseline to hospital discharge, an average of 5-6 days
The incidence of worsening of heart failure case
which is defined as failure of IV diuretic regimen to stabilize the patient state during hospitalization which requires the use of IV inotropic therapy
Measured: Baseline to hospital discharge, an average of 5-6 days.
Fractional Excretion of Sodium (FENa)-based diuretic efficiency
FENa per 40 mg of IV furosemide equivalents of loop dose using spot urine collected 24 hours after continues infusion of loop dose beginning and every day until patients discharge from hospital.
Measured: Baseline to hospital discharge, an average of 5-6 days.
Serum potassium
Serum potassium covariate with attention to both elevation and depression on a daily basis during hospitalization period.
Measured: Baseline to hospital discharge, an average of 5-6 days.
Incidence of ketoacidosis
reporting ketoacidosis
Measured: Baseline to 90 days post discharge
Serum glucose covariate adjusted for baseline with attention to both elevation
(> 400 mg/dL) and depression (< 70 mg/dL).
Measured: Baseline to hospital discharge, an average of 5-6 days.
Incidence of symptomatic, sustained hypovolemic hypotension
systolic blood pressure < 90 mmHg over 30 minutes requiring fluid administration
Measured: Baseline to hospital discharge, an average of 5-6 days.
In-hospital mortality
incidence of mortality
Measured: Baseline to hospital discharge, an average of 5-6 days.
Hospital readmission within 90 days of discharge for heart failure
Re-hospitalization within 90 days from hospital discharge
Measured: within 90 post discharge
Incidence of mortality within 90 days from discharge due cardiovascular cause
Incidence of mortality
Measured: within 90 post discharge
The incidence of worsening of renal function
which is defined as a decline in the e-GFR of 50% or greater from the baseline during any follow-up points
Measured: Baseline to 90 post discharge
Any reported adverse events during follow up period.
ketoacidosis, genital mycotic infection, urinary tract infection, Fournier's gangrene, fractures, or amputation
Measured: within 90 post discharge
The progression of heart failure severity
via measuring Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)
.all KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Measured: within 90 post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start4 Jun 2022
- Primary completion1 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, National Heart Institute, Egypt
- Responsible party
- Principal investigator, rabab ahmed mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364190
- Sponsor's protocol ID
- CL (2973)
- Acronym
- The CANA -AHF
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study results will be duplicated after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Initiation of Canagliflozin in Patients With Acute Decompansted Heart Failure
- ClinicalTrials.gov ID
- NCT05364190
- Acronym / sponsor ID
- The CANA -AHF / CL (2973)
- Keywords
- Canagliflozin, Hospitalized heart failure patients, I.V loop diuretic, NT-proBNP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Cairo University, National Heart Institute, Egypt
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 6 May 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.
The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period.
Detailed description
The study will focus on the role of adding canagliflozin to I.V loop diuretic therapy early in unstable hospitalized acute heart failure patients regardless of diabetic state, patients who will be included in the study will continue on canagliflozin for 3 months after hospital discharge to evaluate the incidence of re-hospitalization, mortality rate and other benefits related to HF symptoms will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A(Intervention group) | Experimental | Drug: Canagliflozinpatients will receive 100 mg canagliflozin initiated within 24 hours from patients hospital admission due to signs of hypervolemic state. All patients also will be prescribed the conventional diuretic therapy and other medications such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI) and mineralocorticoid receptor antagonists (MRAs). Canagliflozin will be continued for 90 days after hospital discharge |
| Group B | Active comparator | Drug: Empagliflozinpatients will receive 10 mg Empagliflozin initiated within 24 hours from patients hospital admission due to signs of a hypervolemic state.All patients also will be prescribed conventional diuretic therapy and other medications including ACEIs, ARBs, beta-blockers, ARNI, and MRAs.Empagliflozin will be continued for 90 days after hospital discharge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Randomized within 24 of presentation during hospital admission for hypervolemic ADHF with evidence of congestion defined by the presence of any of the following signs or symptoms:
- Peripheral edema Ascites Jugular venous pressure > 10 mmHg Orthopnea Paroxysmal nocturnal dyspnea 2.5 kg weight gain Signs of congestion on chest X-ray or lung ultrasound If pulmonary artery catheterization is available pulmonary capillary wedge pressure > 19 mmHg plus a systemic physical examination finding of hypervolemia.
- Planned use of intravenous (IV) loop diuretic therapy during the current hospitalization Estimated glomerular filtration rate (e-GFR) > 30 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Key exclusion criteria (4 listed)
- Type 1 diabetes Serum glucose < 80 mg/dL Systolic blood pressure < 90 mmHg Requirement of IV inotropic therapy History of hypersensitivity to any SGLT-2 inhibitors Already receiving therapy with an SGLT2 inhibitor Women who are pregnant or breastfeeding Severe anemia (Hemoglobin < 7.5 g/dL)(24) Severe uncorrected aortic or mitral stenosis Inability to perform standing weights or measure urine output accurately Signs of ketoacidosis and/or hyperosmolar hyperglycaemic syndrome (pH >7.3 and glucose > 250 mg/dL and HCO3 > 18 mmol/L) in diabetic patients at the time of inclusion to the study.
- The use of other diuretic therapies including; ≥100 mg/day spironolactone doses, ≥ 100 mg/day eplerenone, metolazone, hydrochlorothiazide, or other thiazides, systemic acetazolamide for the indication of diuretics, triamterene, or amiloride therapy.
- The use of other medications possessing natriuretic effect as nesiritide, or arginine vasopressin antagonists.
- Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 18 kg. Severe hepatic impairment (Child-Pugh class C). Patients on hemodialysis Acute myocardial infarction with symptoms of acute ischemia or changes on electrocardiogram
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 |
|---|---|---|
| CanagliflozinCanagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state. | Drug | Group A(Intervention group) |
| EmpagliflozinEmpagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state. | Drug | Group B |
Primary outcome
The cumulative mean of daily diuresis
Time frame: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier
which is define as total urine output in 24 hours during the hospitalization period.
16 secondary outcomes
Measuring diuretic response
Time frame: Baseline to hospital discharge, an average of 5-6 days
The change in the level of NT-pro BNP
Time frame: Baseline to hospital discharge, an average of 5-6 days
Presence of symptoms of congestion and dyspnea at discharge
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Intensive care unit (ICU) length of stay
Time frame: Baseline to hospital discharge, an average of 5-6 days
The incidence of worsening of heart failure case
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Fractional Excretion of Sodium (FENa)-based diuretic efficiency
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Serum potassium
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Incidence of ketoacidosis
Time frame: Baseline to 90 days post discharge
Serum glucose covariate adjusted for baseline with attention to both elevation
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Incidence of symptomatic, sustained hypovolemic hypotension
Time frame: Baseline to hospital discharge, an average of 5-6 days.
In-hospital mortality
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Hospital readmission within 90 days of discharge for heart failure
Time frame: within 90 post discharge
Incidence of mortality within 90 days from discharge due cardiovascular cause
Time frame: within 90 post discharge
The incidence of worsening of renal function
Time frame: Baseline to 90 post discharge
Any reported adverse events during follow up period.
Time frame: within 90 post discharge
The progression of heart failure severity
Time frame: within 90 post discharge
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 11 Jul 2024.
- Individual participant dataSharing planned: Yes. The study results will be duplicated after the end of the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canagliflozin and Empagliflozin in people with Chronic Heart Failure and Acute Heart Failure, run by October 6 University at 1 site in Egypt.
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 11 Jul 2024. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The cumulative mean of daily diuresis (time frame: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier). 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 11 Jul 2024.