SGLT2 Inhibitiors Remodeling EffectNCT06137430
Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
An observational study of SGLT2 Inhibitiors Remodeling Effect and Chronic Heart Disease, run by Assiut University.
Trial summary
To evaluate the efficacy of SGLT2 inhibitors on left ventricular global longitudinal strain and diastology parameters among diabetic and non-diabetic patients with chronic heart failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SGLT2 Inhibitiors Remodeling Effect, Chronic Heart Disease
- What is being tested?
- Sodium-glucose cotransporter 2 inhibitor
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: diabetic and non-diabetic with chronic heart failure patients
Who may be able to join
- The study will enroll outpatients with HF on optimized medical therapy defined by the guidelines of the European Society of Cardiology (ESC) that were used when the study was initiated.
- Age ranges from 18 to 75 years
Who cannot join
- age <18 and > 75 years. 2. If there is any contraindication in using SGLT2 inhibitors, patients that had symptomatic hypotension (systolic blood pressure < 95 mmHg, impaired renal function (eGFR <30ml/min/1.73m2 calculated by the CKD-EPI formula), Potassium serum levels > 5.2 mmol/L and Liver dysfunction (defined as hepatic parameters such as ALT, AST and/or ALP elevated ≥3 times above the upper 99th reference percentile.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the efficacy of SGLT2 inhibitors on left ventricular global longitudinal strain and diastology parameters among diabetic and non-diabetic patients with chronic heart failure
Read the detailed description
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have an established place in the therapy of heart failure (HF), as they have been shown to significantly reduce all-cause mortality, cardiovascular mortality, and hospitalizations in HFrEF patients, regardless of the presence of diabetes mellitus.
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental HF therapy.
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes.
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression, and current well-established HF phenotypes are based on LVEF. However, other relevant players, such as the left atrium, have received less attention. Indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (LV) filling during diastole. Additionally, atrial dysfunction can directly lead to pulmonary congestion. Left atrial (LA) remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF. SGLT2 inhibition has been associated with reduced left ventricular (LV) and left atrial volumes in HF; however, its relationship with contemporary echocardiographic parameters of global LV systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated.
Measuring the effect of SGLT2i therapy on left ventricular systolic function (LV) has previously been assessed by changes in heart size volume and ejection fraction.
In current clinical practice, the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction (LVEF), which remains the gold standard despite some notable limitations.
In the last decade, LV global longitudinal strain (GLS) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical LV systolic dysfunction.
- Being tested
- Sodium-glucose cotransporter 2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-glucose cotransporter 2 inhibitorDrug
Sodium glucose cotransporter 2 inhibitiors
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with chronic heart failure | Not described Receives: Drug: Sodium-glucose cotransporter 2 inhibitor | |
| Non_diabetic patients with chronic heart failure | Not described Receives: Drug: Sodium-glucose cotransporter 2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular global longitudinal strain and diastology parameters, including (left atrial volume indexed) LAVI in chronic heart failure patients on SGLT2 inhibitors, comparing diabetic and non-diabetic patients
Effect of SGLT2 inhibitiors on left ventricular remodeling among diabetic and non diabetic patients with chronic heart failure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SGLT2 Inhibitiors Remodeling EffectStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Abd eltwab Abd elzaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137430
- Sponsor's protocol ID
- Effect of SGLT2 inhibitiors
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06137430
- Acronym / sponsor ID
- Effect of SGLT2 inhibitiors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 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.
To evaluate the efficacy of SGLT2 inhibitors on left ventricular global longitudinal strain and diastology parameters among diabetic and non-diabetic patients with chronic heart failure
Detailed description
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have an established place in the therapy of heart failure (HF), as they have been shown to significantly reduce all-cause mortality, cardiovascular mortality, and hospitalizations in HFrEF patients, regardless of the presence of diabetes mellitus.
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental HF therapy.
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes.
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression, and current well-established HF phenotypes are based on LVEF. However, other relevant players, such as the left atrium, have received less attention. Indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (LV) filling during diastole. Additionally, atrial dysfunction can directly lead to pulmonary congestion. Left atrial (LA) remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF. SGLT2 inhibition has been associated with reduced left ventricular (LV) and left atrial volumes in HF; however, its relationship with contemporary echocardiographic parameters of global LV systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated.
Measuring the effect of SGLT2i therapy on left ventricular systolic function (LV) has previously been assessed by changes in heart size volume and ejection fraction.
In current clinical practice, the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction (LVEF), which remains the gold standard despite some notable limitations.
In the last decade, LV global longitudinal strain (GLS) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical LV systolic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with chronic heart failure | – | Drug: Sodium-glucose cotransporter 2 inhibitor |
| Non_diabetic patients with chronic heart failure | – | Drug: Sodium-glucose cotransporter 2 inhibitor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- diabetic and non-diabetic with chronic heart failure patients
Key inclusion criteria (2 listed)
- The study will enroll outpatients with HF on optimized medical therapy defined by the guidelines of the European Society of Cardiology (ESC) that were used when the study was initiated.
- Age ranges from 18 to 75 years
Key exclusion criteria (1 listed)
- age <18 and > 75 years. 2. If there is any contraindication in using SGLT2 inhibitors, patients that had symptomatic hypotension (systolic blood pressure < 95 mmHg, impaired renal function (eGFR <30ml/min/1.73m2 calculated by the CKD-EPI formula), Potassium serum levels > 5.2 mmol/L and Liver dysfunction (defined as hepatic parameters such as ALT, AST and/or ALP elevated ≥3 times above the upper 99th reference percentile.
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 |
|---|---|---|
| Sodium-glucose cotransporter 2 inhibitorSodium glucose cotransporter 2 inhibitiors | Drug | Diabetic patients with chronic heart failure, Non_diabetic patients with chronic heart failure |
Primary outcome
Left ventricular global longitudinal strain and diastology parameters, including (left atrial volume indexed) LAVI in chronic heart failure patients on SGLT2 inhibitors, comparing diabetic and non-diabetic patients
Time frame: Baseline
Effect of SGLT2 inhibitiors on left ventricular remodeling among diabetic and non diabetic patients with chronic heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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?
An observational study of SGLT2 Inhibitiors Remodeling Effect and Chronic Heart Disease, run by Assiut 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 2 inclusion and 1 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 18 Nov 2023. 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. 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 Ahmad Abd eltwab Abd elzaher, GP (01001806037 ext. 01001806037, ahmedabdeltwab777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular global longitudinal strain and diastology parameters, including (left atrial volume indexed) LAVI in chronic heart failure patients on SGLT2 inhibitors, comparing diabetic and non-diabetic patients (time frame: Baseline). 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 18 Nov 2023.