Heart FailurePhase 4NCT04385589
Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure
A Phase 4 study testing Dapagliflozin and insulin in people with Heart Failure, run by Assiut University at 1 site in Egypt.
Trial summary
We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Dapagliflozin and insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 20 Dec 2020
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
Who cannot join
- Other etiologies of fluid overload different from heart failure.
- Hyponatremia: Sodium level below 125mmol/l
- Unstable patients: acute coronary syndrome, cardiogenic shock .
- Patients requiring inotropic agents or renal dialysis.
- Pregnancy or breastfeeding period.
- sever hepatic disease
- GFR is less than 45 mL/min/1.73 m² .
- Patient with diabetic ketoacidosis or non ketotic hyperosmolar.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF)
We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.
Read the detailed description
The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
Inclusion Criteria:
Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
Age more than 18 years Admission for acute decompensated heart failure The patient already on an oral loop diuretic for at least 1 month before admission, at a dose between 40 mg and 80 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of Torsemide will be considered to be equivalent to 40 mg of furosemide.
Exclusion Criteria:
- Other etiologies of fluid overload different from heart failure.
- Hyponatremia: Sodium level below 125mmol/l
- Unstable patients: acute coronary syndrome, cardiogenic shock .
- Patients requiring inotropic agents or renal dialysis.
- Pregnancy or breastfeeding period.
- sever hepatic disease
- GFR (Glomerular Filtration Rate) is less than 45 mL/min/1.73 m² .
- Patient with diabetic ketoacidosis or non ketotic hyperosmolar. Treatment arm.
The patients will receive:
Loop diuretics. Diuretics should be administered at doses sufficient to achieve optimal volume status and relieve congestion without inducing an excessively rapid reduction in intravascular volume.
furosemide will be given I.V either by continuous infusion or blouses Antifailure treatment: (Angiotensin converting enzyme inhibitors or Angiotensin II Receptor Blockers, Beta Blockers,Mineralocorticoid Receptor Antagonists, Ivabradine, or others will be individualized according to the patient condition.
Dapagliflozin:
will be given in a dose of 10mg once daily ( GFR is more than 45 mL/min/1.73 m²) .
In Mild or moderate hepatic disease: No dosage adjustment required In Severe hepatic disease: will not be used.
Insulin. Insulin therapy should be initiated if blood glucose levels is ≥180 mg/dL (10.0 mmol/L) after initiation of Dapagliflozin treatment. Once insulin therapy is started, a target glucose range of 140-180 mg/dL (7.8-10.0 mmol/L) is recommended The use of subcutaneous rapid- or short-acting insulin before meals or every 4-6 h will be given to correct hyperglycemia according to sliding scale chart.
Control arm.
The patients will be given Loop diuretics. Anti-failure treatment. Insulin.
All the patients will undergo:
- Complete echo assessment.
- ECG on admission and daily.
- Monitoring:24 hours ECG ,Oxygen saturation and blood pressure monitoring. Complete blood count ,blood urea,serum creatinine,blood sugar,electrolytes ,liver function will be measured on admission
- Blood sugar ,urea,creatinine,Na, K will be measured daily along the whole days of admission.
Follow up parameters
Diuresis :24-hour diuresis will be quantified every 24 hours (during hospitalization) from the 1st day until last day of admission.
diuretic response will be measured by weight loss and net fluid loss per mg . Changes in body weight measurements: the mean of weight lost every 24 hours and the total weight lost from baseline to the last day of hospitalization Renal function will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Renal function is assessed with the serum creatinine level. Worsening renal function is defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time during hospitalization Electrolyte levels (sodium and potassium) will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Electrolyte levels are assessed with the serum sodium and potassium levels. Patient-reported dyspnea : Patient-reported dyspnea is assessed every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Patient-reported dyspnea will be assessed with the use five point Linker scale.
- Conditions
- Heart Failure
- Being tested
- Dapagliflozin, insulin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called SGLT-2 inhibitors
Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.
insulinDrug
insulin
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Active comparator | 50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures. Receives: Drug: Dapagliflozin; Drug: insulin |
| Placebo group | Placebo comparator | 50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures. Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight measurement (Diuresis effect.)
Diuretic response will be measured by weight loss
Measured: Days of admission (3-5 days)
Diuresis effect.
Diuretic response will be measured by net fluid loss per mg .
Measured: Days of admission (3-5 days)
Secondary outcomes (2)
Renal function
Renal function is assessed with the serum creatinine level. Worsening renal function is defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time during hospitalization
Measured: Days of admission (3-5 days)
Patient-reported dyspnea will be assessed with the use five point Linker scale
Measured: Days of admission (3-5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 May 2020
- Primary completion15 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelfatah, Assiut University
- Investigators
- Ayman Ibrahem, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385589
- Sponsor's protocol ID
- 3241
- Status last verified
- Feb 2022
- First submitted
- 9 May 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohara K, Masuda T, Morinari M, Okada M, Miki A, Nakagawa S, Murakami T, Oka K, Asakura M, Miyazawa Y, Maeshima A, Akimoto T, Saito O, Nagata D. The extracellular volume status predicts body fluid response to SGLT2 inhibitor dapagliflozin in diabetic kidney disease. Diabetol Metab Syndr. 2020 May 1;12:37. doi: 10.1186/s13098-020-00545-z. eCollection 2020.
PubMed 32377235Elsisi GH, Anwar MM, Khattab M, Elebrashy I, Wafa A, Elhadad H, Awad M, Carapinha JL. Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt. J Med Econ. 2020 Aug;23(8):908-914. doi: 10.1080/13696998.2020.1764571. Epub 2020 May 28.
PubMed 32364032Linden K, Mailey J, Kearney A, Menown IBA. Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials. Adv Ther. 2020 Jun;37(6):2620-2645. doi: 10.1007/s12325-020-01355-5. Epub 2020 May 2.
PubMed 32361851Cappetta D, De Angelis A, Ciuffreda LP, Coppini R, Cozzolino A, Micciche A, Dell'Aversana C, D'Amario D, Cianflone E, Scavone C, Santini L, Palandri C, Naviglio S, Crea F, Rota M, Altucci L, Rossi F, Capuano A, Urbanek K, Berrino L. Amelioration of diastolic dysfunction by dapagliflozin in a non-diabetic model involves coronary endothelium. Pharmacol Res. 2020 Jul;157:104781. doi: 10.1016/j.phrs.2020.104781. Epub 2020 Apr 28.
PubMed 32360273Kasem SM, Saied GM, Hegazy ANM, Abdelsabour M. Impact of Acute Insulin Resistance on Myocardial Blush in Non-Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention. Front Cardiovasc Med. 2021 May 10;8:647366. doi: 10.3389/fcvm.2021.647366. eCollection 2021.
PubMed 34041280Ibrahim A, Ghaleb R, Mansour H, Hanafy A, Mahmoud NM, Abdelfatah Elsharef M, Kamal Salama M, Elsaughier SM, Abdel-Wahid L, Embarek Mohamed M, Ibrahim AK, Abdel-Galeel A. Safety and Efficacy of Adding Dapagliflozin to Furosemide in Type 2 Diabetic Patients With Decompensated Heart Failure and Reduced Ejection Fraction. Front Cardiovasc Med. 2020 Dec 7;7:602251. doi: 10.3389/fcvm.2020.602251. eCollection 2020.
PubMed 33426003
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF)
- ClinicalTrials.gov ID
- NCT04385589
- Acronym / sponsor ID
- 3241
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 13 May 2020 (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.
We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.
Detailed description
The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
Inclusion Criteria:
Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
Age more than 18 years Admission for acute decompensated heart failure The patient already on an oral loop diuretic for at least 1 month before admission, at a dose between 40 mg and 80 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of Torsemide will be considered to be equivalent to 40 mg of furosemide.
Exclusion Criteria:
- Other etiologies of fluid overload different from heart failure.
- Hyponatremia: Sodium level below 125mmol/l
- Unstable patients: acute coronary syndrome, cardiogenic shock .
- Patients requiring inotropic agents or renal dialysis.
- Pregnancy or breastfeeding period.
- sever hepatic disease
- GFR (Glomerular Filtration Rate) is less than 45 mL/min/1.73 m² .
- Patient with diabetic ketoacidosis or non ketotic hyperosmolar. Treatment arm.
The patients will receive:
Loop diuretics. Diuretics should be administered at doses sufficient to achieve optimal volume status and relieve congestion without inducing an excessively rapid reduction in intravascular volume.
furosemide will be given I.V either by continuous infusion or blouses Antifailure treatment: (Angiotensin converting enzyme inhibitors or Angiotensin II Receptor Blockers, Beta Blockers,Mineralocorticoid Receptor Antagonists, Ivabradine, or others will be individualized according to the patient condition.
Dapagliflozin:
will be given in a dose of 10mg once daily ( GFR is more than 45 mL/min/1.73 m²) .
In Mild or moderate hepatic disease: No dosage adjustment required In Severe hepatic disease: will not be used.
Insulin. Insulin therapy should be initiated if blood glucose levels is ≥180 mg/dL (10.0 mmol/L) after initiation of Dapagliflozin treatment. Once insulin therapy is started, a target glucose range of 140-180 mg/dL (7.8-10.0 mmol/L) is recommended The use of subcutaneous rapid- or short-acting insulin before meals or every 4-6 h will be given to correct hyperglycemia according to sliding scale chart.
Control arm.
The patients will be given Loop diuretics. Anti-failure treatment. Insulin.
All the patients will undergo:
- Complete echo assessment.
- ECG on admission and daily.
- Monitoring:24 hours ECG ,Oxygen saturation and blood pressure monitoring. Complete blood count ,blood urea,serum creatinine,blood sugar,electrolytes ,liver function will be measured on admission
- Blood sugar ,urea,creatinine,Na, K will be measured daily along the whole days of admission.
Follow up parameters
Diuresis :24-hour diuresis will be quantified every 24 hours (during hospitalization) from the 1st day until last day of admission.
diuretic response will be measured by weight loss and net fluid loss per mg . Changes in body weight measurements: the mean of weight lost every 24 hours and the total weight lost from baseline to the last day of hospitalization Renal function will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Renal function is assessed with the serum creatinine level. Worsening renal function is defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time during hospitalization Electrolyte levels (sodium and potassium) will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Electrolyte levels are assessed with the serum sodium and potassium levels. Patient-reported dyspnea : Patient-reported dyspnea is assessed every 24 hours (during hospitalization) from the date of admission until the date of discharge.
Patient-reported dyspnea will be assessed with the use five point Linker scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin, Drug: insulin50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures. |
| Placebo group | Placebo comparator | Drug: insulin50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
Key exclusion criteria (8 listed)
- Other etiologies of fluid overload different from heart failure.
- Hyponatremia: Sodium level below 125mmol/l
- Unstable patients: acute coronary syndrome, cardiogenic shock .
- Patients requiring inotropic agents or renal dialysis.
- Pregnancy or breastfeeding period.
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: SGLT-2 inhibitorsPatient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome. | Drug | Dapagliflozin group |
| insulininsulin | Drug | Dapagliflozin group, Placebo group |
Primary outcome
Changes in body weight measurement (Diuresis effect.)
Time frame: Days of admission (3-5 days)
Diuretic response will be measured by weight loss
Diuresis effect.
Time frame: Days of admission (3-5 days)
Diuretic response will be measured by net fluid loss per mg .
2 secondary outcomes
Renal function
Time frame: Days of admission (3-5 days)
Patient-reported dyspnea will be assessed with the use five point Linker scale
Time frame: Days of admission (3-5 days)
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 16 Feb 2022.
- Background: PubMed 32377235Ohara K, Masuda T, Morinari M, Okada M, Miki A, Nakagawa S, Murakami T, Oka K, Asakura M, Miyazawa Y, Maeshima A, Akimoto T, Saito O, Nagata D. The extracellular volume status predicts body fluid response to SGLT2 inhibitor dapagliflozin in diabetic kidney disease. Diabetol Metab Syndr. 2020 May 1;12:37. doi: 10.1186/s13098-020-00545-z. eCollection 2020.
- Background: PubMed 32364032Elsisi GH, Anwar MM, Khattab M, Elebrashy I, Wafa A, Elhadad H, Awad M, Carapinha JL. Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt. J Med Econ. 2020 Aug;23(8):908-914. doi: 10.1080/13696998.2020.1764571. Epub 2020 May 28.
- Background: PubMed 32361851Linden K, Mailey J, Kearney A, Menown IBA. Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials. Adv Ther. 2020 Jun;37(6):2620-2645. doi: 10.1007/s12325-020-01355-5. Epub 2020 May 2.
- Background: PubMed 32360273Cappetta D, De Angelis A, Ciuffreda LP, Coppini R, Cozzolino A, Micciche A, Dell'Aversana C, D'Amario D, Cianflone E, Scavone C, Santini L, Palandri C, Naviglio S, Crea F, Rota M, Altucci L, Rossi F, Capuano A, Urbanek K, Berrino L. Amelioration of diastolic dysfunction by dapagliflozin in a non-diabetic model involves coronary endothelium. Pharmacol Res. 2020 Jul;157:104781. doi: 10.1016/j.phrs.2020.104781. Epub 2020 Apr 28.
- Derived from this study: PubMed 34041280Kasem SM, Saied GM, Hegazy ANM, Abdelsabour M. Impact of Acute Insulin Resistance on Myocardial Blush in Non-Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention. Front Cardiovasc Med. 2021 May 10;8:647366. doi: 10.3389/fcvm.2021.647366. eCollection 2021.
- Derived from this study: PubMed 33426003Ibrahim A, Ghaleb R, Mansour H, Hanafy A, Mahmoud NM, Abdelfatah Elsharef M, Kamal Salama M, Elsaughier SM, Abdel-Wahid L, Embarek Mohamed M, Ibrahim AK, Abdel-Galeel A. Safety and Efficacy of Adding Dapagliflozin to Furosemide in Type 2 Diabetic Patients With Decompensated Heart Failure and Reduced Ejection Fraction. Front Cardiovasc Med. 2020 Dec 7;7:602251. doi: 10.3389/fcvm.2020.602251. eCollection 2020.
- 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.
Ayman Ibrahem, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin and insulin in people with Heart Failure, run by Assiut 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 1 inclusion and 8 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 16 Feb 2022. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes in body weight measurement (Diuresis effect.) (time frame: Days of admission (3-5 days)). The study lists 2 primary outcomes in all. 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 NCT04385589, which also lists 6 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 16 Feb 2022.