Heart FailureNCT05727423
Dapagliflozin in the Treatment of Heart Failure
An observational study of Heart Failure, run by Helwan University at 1 site in Egypt.
Trial summary
prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Heart Failure
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Feb 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 19 to 75 years
- All sexes
- Adult, Older adult
Study population: In the cardiology department at Ain Shams university hospitals, stable heart failure patients with reduced ejection fraction should fulfill the inclusion and exclusion criteria mentioned above.
Who may be able to join
- patients age > 18 years
- Diagnosis of heart failure NYHA class II- IV
- LVEF ≤ 40% on echocardiography
Who cannot join
- Estimated glomerular filtration rate <30 ml/min/1.73m2
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Dapagliflozin in the Treatment of Heart Failure in Non-diabetic Egyptian Patients
prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction
Read the detailed description
Heart failure (HF) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. From a physiological point of view, HF can be defined as an inadequate cardiac output to meet metabolic demands.
HF is a growing public health problem, with an estimated 63 million people affected worldwide , with HF being the underlying cause of more than 1 million hospitalizations every year. These hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), In addition, the prevalence of patient with HF and reduced ejection fraction (HFrEF) is higher and has greater mortality rates than those with preserved ejection fraction (HFpEF).
Sodium-glucose Cotransporter-2(SGLT2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes .
More recently, the DAPA-HF trial which showed that dapagliflozin significantly improved the outcomes of patients with HFrEF and reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% irrespective of the presence or absence of T2DM, demonstrated the significance of SGLT2 inhibitors as novel therapeutic agents in heart failure.
In May 2020,The FDA approved AstraZeneca's dapagliflozin (Forxiga) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes (T2D), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.
This study is established to investigate safety and efficacy of dapagliflozin in non-diabetic patients with heart failure.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction
Assessment of Echo parameters of LV-systolic function as EF
Measured: 6 months
Secondary outcomes (2)
left ventricular end-systolic volume, left ventricular end-diastolic volume
Assessment of Echo parameters of LV-systolic function as LVESV, LVEDV
Measured: 6 months
E/e', LAVI, septal e'
Assessment of Echo parameters of LV- diastolic function as E/e', LAVI, septal e'
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Sep 2021
- Primary completion28 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madonna salama hanna, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727423
- Sponsor's protocol ID
- 05H2021
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
Publications
Coronel R, de Groot JR, van Lieshout JJ. Defining heart failure. Cardiovasc Res. 2001 Jun;50(3):419-22. doi: 10.1016/s0008-6363(01)00284-x. No abstract available.
PubMed 11376615Lam CSP, Gamble GD, Ling LH, Sim D, Leong KTG, Yeo PSD, Ong HY, Jaufeerally F, Ng TP, Cameron VA, Poppe K, Lund M, Devlin G, Troughton R, Richards AM, Doughty RN. Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study. Eur Heart J. 2018 May 21;39(20):1770-1780. doi: 10.1093/eurheartj/ehy005.
PubMed 29390051McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829Rahmoune H, Thompson PW, Ward JM, Smith CD, Hong G, Brown J. Glucose transporters in human renal proximal tubular cells isolated from the urine of patients with non-insulin-dependent diabetes. Diabetes. 2005 Dec;54(12):3427-34. doi: 10.2337/diabetes.54.12.3427.
PubMed 16306358
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dapagliflozin in the Treatment of Heart Failure in Non-diabetic Egyptian Patients
- ClinicalTrials.gov ID
- NCT05727423
- Acronym / sponsor ID
- 05H2021
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 14 Feb 2023 (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.
prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction
Detailed description
Heart failure (HF) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. From a physiological point of view, HF can be defined as an inadequate cardiac output to meet metabolic demands.
HF is a growing public health problem, with an estimated 63 million people affected worldwide , with HF being the underlying cause of more than 1 million hospitalizations every year. These hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), In addition, the prevalence of patient with HF and reduced ejection fraction (HFrEF) is higher and has greater mortality rates than those with preserved ejection fraction (HFpEF).
Sodium-glucose Cotransporter-2(SGLT2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes .
More recently, the DAPA-HF trial which showed that dapagliflozin significantly improved the outcomes of patients with HFrEF and reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% irrespective of the presence or absence of T2DM, demonstrated the significance of SGLT2 inhibitors as novel therapeutic agents in heart failure.
In May 2020,The FDA approved AstraZeneca's dapagliflozin (Forxiga) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes (T2D), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.
This study is established to investigate safety and efficacy of dapagliflozin in non-diabetic patients with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In the cardiology department at Ain Shams university hospitals, stable heart failure patients with reduced ejection fraction should fulfill the inclusion and exclusion criteria mentioned above.
Key inclusion criteria (3 listed)
- patients age > 18 years
- Diagnosis of heart failure NYHA class II- IV
- LVEF ≤ 40% on echocardiography
Key exclusion criteria (2 listed)
- Estimated glomerular filtration rate <30 ml/min/1.73m2
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
left ventricular ejection fraction
Time frame: 6 months
Assessment of Echo parameters of LV-systolic function as EF
2 secondary outcomes
left ventricular end-systolic volume, left ventricular end-diastolic volume
Time frame: 6 months
E/e', LAVI, septal e'
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 11376615Coronel R, de Groot JR, van Lieshout JJ. Defining heart failure. Cardiovasc Res. 2001 Jun;50(3):419-22. doi: 10.1016/s0008-6363(01)00284-x. No abstract available.
- Background: PubMed 29390051Lam CSP, Gamble GD, Ling LH, Sim D, Leong KTG, Yeo PSD, Ong HY, Jaufeerally F, Ng TP, Cameron VA, Poppe K, Lund M, Devlin G, Troughton R, Richards AM, Doughty RN. Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study. Eur Heart J. 2018 May 21;39(20):1770-1780. doi: 10.1093/eurheartj/ehy005.
- Background: PubMed 31535829McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- Background: PubMed 16306358Rahmoune H, Thompson PW, Ward JM, Smith CD, Hong G, Brown J. Glucose transporters in human renal proximal tubular cells isolated from the urine of patients with non-insulin-dependent diabetes. Diabetes. 2005 Dec;54(12):3427-34. doi: 10.2337/diabetes.54.12.3427.
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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?
An observational study of Heart Failure, run by Helwan 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 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 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.
Are results available for this study?
Results are not available in the source record.
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?
left ventricular ejection fraction (time frame: 6 months). 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 NCT05727423, which also lists 4 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 29 Jan 2024.