Heart Failure with Preserved Ejection FractionNCT06510270
Dapagliflozin in Reducing Epicardial Adipose Tissue in Heart Failure with Preserved Ejection Fraction
A study testing Dapagliflozin 10 mg once daily, Loop diuretics and Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic) in people with Heart Failure with Preserved Ejection Fraction, run by Aswan University.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is becoming the most common cause of heart failure worldwide, in part, driven by a rising prevalence of obesity. Although generalized and visceral adiposity is important in the pathogenesis of obesity-related HFpEF, there is increasing recognition of the potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure with Preserved Ejection Fraction
- What is being tested?
- Dapagliflozin 10 mg once daily, Loop diuretics and Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Oct 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age \>18 years.
- Patients with established diagnosis of HFpEF: (1. Signs and Symptoms of Heart Failure. 2. Preserved Ejection Fraction (EF): EF greater than or equal to 50% is generally considered preserved. 3.Echo-cardiography: Evidence of left ventricular hypertrophy (LVH) or Evidence of diastolic dysfunction, such as impaired relaxation or increased stiffness of the left ventricle. 4.Elevated Natriuretic Peptides: serum N-terminal pro-B type natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide ≥100 pg/mL can support the diagnosis of HFpEF in the presence of symptoms and other findings).
- BMI \>27Kg/m2.
- Adequate follow-up: Participants must be willing and able to comply with the study protocol and follow-up requirements.
Who cannot join
- 1. Age \<18 years. 2. Type 1 diabetes: Exclude individuals with type 1 diabetes, as dapagliflozin is primarily used for type 2 diabetes management.
- 3. Significant renal impairment: Exclude participants with severe renal impairment or end-stage renal disease.
- 4. Severe hepatic impairment: Exclude participants with severe hepatic dysfunction.
- 5. Pregnancy or breastfeeding: Exclude pregnant or lactating individuals. 6. Patients who underwent Bariateric surgery. 7. BMI\<27Kg/m2. 8. Other serious medical conditions: Exclude participants with serious medical conditions that could interfere with the study or confound the results (e.g., cancer, severe infections).
- 9. Inability to comply: Exclude participants who are unable or unwilling to comply with the study procedures and requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Targeting Epicardial Adipose Tissue in Heart Failure with Preserved Ejection Fraction: Exploring the Dapagliflozin Connection
Heart failure with preserved ejection fraction (HFpEF) is becoming the most common cause of heart failure worldwide, in part, driven by a rising prevalence of obesity.
Although generalized and visceral adiposity is important in the pathogenesis of obesity-related HFpEF, there is increasing recognition of the potential role of epicardial adipose tissue (EAT) in disease pathogenesis. EAT is metabolically active tissue located directly on the surface of the myocardium underneath the visceral pericardium. By virtue of its anatomical interface with the heart and the lack of fascial separation between the underlying myocardium and epicardial fat, locally secreted adipokines directly bathe the surface of the heart and result in underlying myocardial remodeling.
Read more
Its position on the surface of the myocardium allows EAT to directly contribute to an increase in total heart size with stretch of the pericardium and results in relative pericardial restraint with constrictive physiology.
EAT is most commonly measured by echocardiography in the parasternal long axis view perpendicular to the right ventricle (RV) to quantify epicardial fat thickness and this has been correlated with worse haemodynamic derangements and adverse outcomes in HFpEF.
Alternatively, cardiac MRI or CT can provide a more complete volumetric assessment of epicardial fat volume and has also demonstrated associations with adverse outcomes and functional metrics in most but not all HFpEF studies.
Very little is understood about the impact of medical modulation of epicardial fat in HFpEF. The first proven agents to improve heart failure hospitalization and quality of life in HFpEF are the sodium-glucose cotransporter-2 inhibitors (SGLT2i) Although the mechanisms of benefit of these drugs are uncertain, they have demonstrated a reduction in epicardial fat despite only minimal weight loss suggesting a direct lipolytic effect on epicardial fat. The use of SGLT2i has also been associated with reduced incident AF, which may, in part, be due to the reduction in epicardial fat. The diuretic effect of SGLT2i may facilitate a reduction in plasma volume and mechanistic studies have shown that they also promote ventricular mass regression, which may cumulatively decrease pericardial restraint.
By this work we aims To determine whether the addition of 10 mg of Dapagliflozin to a patient with HFPEF can lead to a decrease in epicardial adipose tissue volume, which is a new approach to managing HFPEF or not.
- Being tested
- Dapagliflozin 10 mg once daily, Loop diuretics, Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)
- Keywords
- HFpEF, Dapagliflozin, epicardial adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mg once dailyDrug
Dapagliflozin 10 mg once daily will be given to all patients in symptomstic heart failure group
Loop diureticsDrug
Loop diuretics (IV or orally) will be given to all patients in symptomatic heart failure group
Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)Drug
Treatment of associated co-morbidities will be given to both arms (group) such as anti-hypertensive (B blockers, ACIE, ARBS, CA channel blockers, Diuretics), oral hypoglycemic (Metformins, sulfonyl urea,.......)
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic heart failure | Active comparator | Patients with clinical manifictations of heart failure but preserved ejection fraction by echocardiography. Receives: Drug: Dapagliflozin 10 mg once daily; Drug: Loop diuretics; Drug: Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic) |
| Asymptomatic Diastolic dysfunction | Placebo comparator | Patients with diastolic dysfunction grade II or more by Echocardiography but with out any heart failure manifictation. Receives: Drug: Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Epicardial adipose tissue volume
epicardial adipose tissue volume (gm) will be measured by using CMR before starting Dapagliflozin in sympotomatic heart failure group and 6 months latter. In asymptomatic diastolic dysfunction CMR will be performed at enrollment and 6 month latter
Measured: from enrollment (before stsrting dapagliflozin) to 6 month (while still on dapagliflozin)
Secondary outcomes (3)
Change in Body mass index
body mass index (kg/m2) will be measured at enrollment for both groups and 6 month latter at the end of the study
Measured: At enrollement till 6 months latter
Recurrent hospital admission by heart failure
Number of recurrent hospital admission by heart failure for each participant from enrollment till th end of study (6 month latter) will be recorded
Measured: From enrollement till 6 months latter
Cardio-vascular mortality
Cardiovascular mortality rate (due to stroke or MI) will be measured for both groups
Measured: From enrollement till 6 months latter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure with Preserved Ejection FractionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Soliman, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510270
- Sponsor's protocol ID
- 865/11/23
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soliman AM, Ghaleb R, Mahmoud AH, Heidar MAA, Ibrahim A. Targeting epicardial adipose tissue in heart failure with preserved ejection fraction: exploring the dapagliflozin connection. BMC Cardiovasc Disord. 2026 Apr 22;26(1):359. doi: 10.1186/s12872-026-05819-4.
PubMed 42021144
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Epicardial Adipose Tissue in Heart Failure with Preserved Ejection Fraction: Exploring the Dapagliflozin Connection
- ClinicalTrials.gov ID
- NCT06510270
- Acronym / sponsor ID
- 865/11/23
- Keywords
- HFpEF, Dapagliflozin, epicardial adipose tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
Heart failure with preserved ejection fraction (HFpEF) is becoming the most common cause of heart failure worldwide, in part, driven by a rising prevalence of obesity.
Although generalized and visceral adiposity is important in the pathogenesis of obesity-related HFpEF, there is increasing recognition of the potential role of epicardial adipose tissue (EAT) in disease pathogenesis. EAT is metabolically active tissue located directly on the surface of the myocardium underneath the visceral pericardium. By virtue of its anatomical interface with the heart and the lack of fascial separation between the underlying myocardium and epicardial fat, locally secreted adipokines directly bathe the surface of the heart and result in underlying myocardial remodeling.
Its position on the surface of the myocardium allows EAT to directly contribute to an increase in total heart size with stretch of the pericardium and results in relative pericardial restraint with constrictive physiology.
EAT is most commonly measured by echocardiography in the parasternal long axis view perpendicular to the right ventricle (RV) to quantify epicardial fat thickness and this has been correlated with worse haemodynamic derangements and adverse outcomes in HFpEF.
Alternatively, cardiac MRI or CT can provide a more complete volumetric assessment of epicardial fat volume and has also demonstrated associations with adverse outcomes and functional metrics in most but not all HFpEF studies.
Very little is understood about the impact of medical modulation of epicardial fat in HFpEF. The first proven agents to improve heart failure hospitalization and quality of life in HFpEF are the sodium-glucose cotransporter-2 inhibitors (SGLT2i) Although the mechanisms of benefit of these drugs are uncertain, they have demonstrated a reduction in epicardial fat despite only minimal weight loss suggesting a direct lipolytic effect on epicardial fat. The use of SGLT2i has also been associated with reduced incident AF, which may, in part, be due to the reduction in epicardial fat. The diuretic effect of SGLT2i may facilitate a reduction in plasma volume and mechanistic studies have shown that they also promote ventricular mass regression, which may cumulatively decrease pericardial restraint.
By this work we aims To determine whether the addition of 10 mg of Dapagliflozin to a patient with HFPEF can lead to a decrease in epicardial adipose tissue volume, which is a new approach to managing HFPEF or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic heart failure | Active comparator | Drug: Dapagliflozin 10 mg once daily, Drug: Loop diuretics, Drug: Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)Patients with clinical manifictations of heart failure but preserved ejection fraction by echocardiography. |
| Asymptomatic Diastolic dysfunction | Placebo comparator | Drug: Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)Patients with diastolic dysfunction grade II or more by Echocardiography but with out any heart failure manifictation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age \>18 years.
- Patients with established diagnosis of HFpEF: (1. Signs and Symptoms of Heart Failure. 2. Preserved Ejection Fraction (EF): EF greater than or equal to 50% is generally considered preserved. 3.Echo-cardiography: Evidence of left ventricular hypertrophy (LVH) or Evidence of diastolic dysfunction, such as impaired relaxation or increased stiffness of the left ventricle. 4.Elevated Natriuretic Peptides: serum N-terminal pro-B type natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide ≥100 pg/mL can support the diagnosis of HFpEF in the presence of symptoms and other findings).
- BMI \>27Kg/m2.
- Adequate follow-up: Participants must be willing and able to comply with the study protocol and follow-up requirements.
Key exclusion criteria (5 listed)
- 1. Age \<18 years. 2. Type 1 diabetes: Exclude individuals with type 1 diabetes, as dapagliflozin is primarily used for type 2 diabetes management.
- 3. Significant renal impairment: Exclude participants with severe renal impairment or end-stage renal disease.
- 4. Severe hepatic impairment: Exclude participants with severe hepatic dysfunction.
- 5. Pregnancy or breastfeeding: Exclude pregnant or lactating individuals. 6. Patients who underwent Bariateric surgery. 7. BMI\<27Kg/m2. 8. Other serious medical conditions: Exclude participants with serious medical conditions that could interfere with the study or confound the results (e.g., cancer, severe infections).
- 9. Inability to comply: Exclude participants who are unable or unwilling to comply with the study procedures and requirements.
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 |
|---|---|---|
| Dapagliflozin 10 mg once dailyDapagliflozin 10 mg once daily will be given to all patients in symptomstic heart failure group | Drug | Symptomatic heart failure |
| Loop diureticsLoop diuretics (IV or orally) will be given to all patients in symptomatic heart failure group | Drug | Symptomatic heart failure |
| Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic)Treatment of associated co-morbidities will be given to both arms (group) such as anti-hypertensive (B blockers, ACIE, ARBS, CA channel blockers, Diuretics), oral hypoglycemic (Metformins, sulfonyl urea,.......) | Drug | Asymptomatic Diastolic dysfunction, Symptomatic heart failure |
Primary outcome
Reduction in Epicardial adipose tissue volume
Time frame: from enrollment (before stsrting dapagliflozin) to 6 month (while still on dapagliflozin)
epicardial adipose tissue volume (gm) will be measured by using CMR before starting Dapagliflozin in sympotomatic heart failure group and 6 months latter. In asymptomatic diastolic dysfunction CMR will be performed at enrollment and 6 month latter
3 secondary outcomes
Change in Body mass index
Time frame: At enrollement till 6 months latter
Recurrent hospital admission by heart failure
Time frame: From enrollement till 6 months latter
Cardio-vascular mortality
Time frame: From enrollement till 6 months latter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 42021144Soliman AM, Ghaleb R, Mahmoud AH, Heidar MAA, Ibrahim A. Targeting epicardial adipose tissue in heart failure with preserved ejection fraction: exploring the dapagliflozin connection. BMC Cardiovasc Disord. 2026 Apr 22;26(1):359. doi: 10.1186/s12872-026-05819-4.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10 mg once daily, Loop diuretics and Treatments of associated co-morbidities (e.g Anti-hypertensive, oral hypoglycemic) in people with Heart Failure with Preserved Ejection Fraction, run by Aswan University.
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 4 inclusion and 5 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Aml Mohammed Soliman, M.D (+21140898257, aml.mohamed@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Epicardial adipose tissue volume (time frame: from enrollment (before stsrting dapagliflozin) to 6 month (while still on dapagliflozin)). 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 NCT06510270, which also lists 1 linked publication.
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 19 Jul 2024.