Genetic PolymorphismsNCT06201000
Effect of Genetic Polymorphisms on the Clinical Response to SGLT2 Inhibitors in Heart Failure Patients
An observational study of Genetic Polymorphisms and Heart Failure, run by October 6 University at 1 site in United States.
Trial summary
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Genetic Polymorphisms, Heart Failure
- What is being tested?
- SGLT2 inhibitors (Dapagliflozin and Empagliflozin)
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 1 Sep 2024
- How long will I take part?
- 6 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consist of established Heart failure with reduced ejection fraction (HFrEF) or Heart failure with preserved ejection fraction (HFpEF) and New York Heart Association (NYHA) functional classes II-III, who will be candidates for add-on treatment with SGLT2i.
Who may be able to join
- Heart failure patients NYHA class II to III.
- Heart failure patients with reduced left ventricular ejection fraction (LVEF) < 45% or with preserved left ventricular ejection fraction (LVEF) > 45%
- Patients who will be candidate for add-on treatment with SGLT2.
- Patients who will be able to sign informed consent to participate in the study.
Who cannot join
- Contraindications to SGLT2.
- Significant coronary artery diseases (CAD), coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or valve surgery within 3 months.
- Pregnant or breastfeeding women.
- Patients with estimated glomerular filtration rates less than 30 mL/min/1.73 m2, as determined using the CKD-EPI equation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Julio Duarte, PhD
About this study
Official title: Effect of Genetic Polymorphisms on the Clinical Response to Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors in Prevention of Cardiac Remodeling and Fibrosis in Heart Failure Patients
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients.
The SGLT2 gene, also known as SLC5A2 (solute carrier family 5 member 2), is located on chromosome 16 and is responsible for encoding SGLT2.
Several SLC5A2 mutations alter SGLT2 expression, membrane location, or transporter function.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
Read the detailed description
Sodium-glucose cotransporter-2 inhibitors (SGLT-2i), which were first investigated and licensed for the treatment of diabetes, are now emerging as a promising class of drugs for the treatment of heart failure (HF), even in people without diabetes.
Significant reductions in worsening heart failure or cardiovascular death were shown under treatment with dapagliflozin and empagliflozin in the trials of patients with heart failure.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
The most recent SLC5A2 Single Nucleotide Polymorphisms (SNPs) that reduce the risk of heart failure included two intronic SLC5A2 SNPs, s9934336, and rs3116150, both associated with the expression levels of the transporter.
This study aims to detect the association between SLC5A2 single nucleotide polymorphisms and variability in response to SGLT2 Inhibitors as well as the association between cardiac biomarkers and non-coding RNA in patients with Heart Failure.
- Conditions
- Genetic Polymorphisms, Heart Failure
- Being tested
- SGLT2 inhibitors (Dapagliflozin and Empagliflozin)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitors (Dapagliflozin and Empagliflozin)Drug
Also called Forxiga, Jardiance
10 mg of dapagliflozin or empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients with reduced or preserved Ejection Fraction | Patients with reduced or preserved ejection fraction that have received the Guided Therapy (β-blockers, Diuretics, Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARBs) or Angiotensin Receptor-Neprilysin Inhibitor (ARNi) and Mineralocorticoid receptor antagonists (MRAs) then Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) (10 mg of dapagliflozin or empagliflozin) will be added at the study entry. Receives: Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms
Change in median / mean of Left Ventricular Ejection Fraction (LVEF) before and after drug administration
Measured: 6 months
Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms
Change in median / mean of Left Ventricular End Systolic Volume (LVESV)
Measured: 6 months
Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms
Change in median / mean of Left Ventricular End Diastolic Volume (LVEDV) before and after drug administration
Measured: 6 months
Secondary outcomes (1)
Median / Mean of quality of life measure {Kansas City Cardiomyopathy Questionnaire (KCCQ-12)} among studied genetic polymorphisms
Change in median / mean of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) before and after drug administration
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 posted11 Jan 2024
- Study start27 Dec 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PolymorphismsStudies 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
- 282 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, National Heart Institute, Egypt, Beni-Suef University
- Responsible party
- Principal investigator, Ahmed Essam, October 6 University
- Investigators
- Rania Sarhan, PhD, Study director, Beni-Suef UniversityNeven Sarhan, PhD, Study director, Misr International UniversityBassem Zarif, MD, Study director, National Heart InstituteJulio Duarte, PhD, Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201000
- Sponsor's protocol ID
- IHC00068
- Status last verified
- Feb 2024
- First submitted
- 27 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Polymorphisms on the Clinical Response to Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors in Prevention of Cardiac Remodeling and Fibrosis in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06201000
- Acronym / sponsor ID
- IHC00068
- Conditions
- Genetic Polymorphisms, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- University of Florida, National Heart Institute, Egypt, Beni-Suef University
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Jan 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.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients.
The SGLT2 gene, also known as SLC5A2 (solute carrier family 5 member 2), is located on chromosome 16 and is responsible for encoding SGLT2.
Several SLC5A2 mutations alter SGLT2 expression, membrane location, or transporter function.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
Detailed description
Sodium-glucose cotransporter-2 inhibitors (SGLT-2i), which were first investigated and licensed for the treatment of diabetes, are now emerging as a promising class of drugs for the treatment of heart failure (HF), even in people without diabetes.
Significant reductions in worsening heart failure or cardiovascular death were shown under treatment with dapagliflozin and empagliflozin in the trials of patients with heart failure.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
The most recent SLC5A2 Single Nucleotide Polymorphisms (SNPs) that reduce the risk of heart failure included two intronic SLC5A2 SNPs, s9934336, and rs3116150, both associated with the expression levels of the transporter.
This study aims to detect the association between SLC5A2 single nucleotide polymorphisms and variability in response to SGLT2 Inhibitors as well as the association between cardiac biomarkers and non-coding RNA in patients with Heart Failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients with reduced or preserved Ejection Fraction | – | Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)Patients with reduced or preserved ejection fraction that have received the Guided Therapy (β-blockers, Diuretics, Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARBs) or Angiotensin Receptor-Neprilysin Inhibitor (ARNi) and Mineralocorticoid receptor antagonists (MRAs) then Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) (10 mg of dapagliflozin or empagliflozin) will be added at the study entry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of established Heart failure with reduced ejection fraction (HFrEF) or Heart failure with preserved ejection fraction (HFpEF) and New York Heart Association (NYHA) functional classes II-III, who will be candidates for add-on treatment with SGLT2i.
Key inclusion criteria (4 listed)
- Heart failure patients NYHA class II to III.
- Heart failure patients with reduced left ventricular ejection fraction (LVEF) < 45% or with preserved left ventricular ejection fraction (LVEF) > 45%
- Patients who will be candidate for add-on treatment with SGLT2.
- Patients who will be able to sign informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Contraindications to SGLT2.
- Significant coronary artery diseases (CAD), coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or valve surgery within 3 months.
- Pregnant or breastfeeding women.
- Patients with estimated glomerular filtration rates less than 30 mL/min/1.73 m2, as determined using the CKD-EPI equation.
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 |
|---|---|---|
| SGLT2 inhibitors (Dapagliflozin and Empagliflozin)Also: Forxiga, Jardiance10 mg of dapagliflozin or empagliflozin | Drug | Heart Failure Patients with reduced or preserved Ejection Fraction |
Primary outcome
Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms
Time frame: 6 months
Change in median / mean of Left Ventricular Ejection Fraction (LVEF) before and after drug administration
Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms
Time frame: 6 months
Change in median / mean of Left Ventricular End Systolic Volume (LVESV)
Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms
Time frame: 6 months
Change in median / mean of Left Ventricular End Diastolic Volume (LVEDV) before and after drug administration
1 secondary outcome
Median / Mean of quality of life measure {Kansas City Cardiomyopathy Questionnaire (KCCQ-12)} among studied genetic polymorphisms
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 7 Feb 2024.
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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.
Rania Sarhan, PhD study director
Beni-Suef University
Neven Sarhan, PhD study director
Misr International University
Bassem Zarif, MD study director
National Heart Institute
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 Genetic Polymorphisms and Heart Failure, run by October 6 University at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 7 Feb 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 United States. 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?
Contact Ahmed Essam, MSc (+201007647696, ahmed.essam@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms (time frame: 6 months). The study lists 3 primary outcomes in all. 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 7 Feb 2024.