Rheumatic Heart DiseaseNCT06097585
Gliflozins on HF in Regurgitant Rheumatic Heart
An observational study of Rheumatic Heart Disease and Heart Failure, run by Assiut University.
Trial summary
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Heart Disease, Heart Failure
- What is being tested?
- SGLT2 inhibitor
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending outpatient clinic, cardiology department, Assiut university hospital and south valley university hospital
Who may be able to join
- All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion
- Patients aged 18 years or older at time of inclusion in the study
- Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
- Body Mass Index (BMI) < 45 kg/m2
Who cannot join
- Advanced stage liver and kidney failure (glomerular filtration rate < 20 mL/min/1.73 m2).
- Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD)
- Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,…..etc within the 12 months prior to Visit 1
- Known allergy or hypersensitivity to SGLT-2 inhibitors
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- ongoing hematological diseases and malignancies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Gliflozins on Heart Failure Due to Regurgitant Rheumatic Valve Disease
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
Read the detailed description
- Rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group A β hemolytic Streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. Damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. Complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation .
- Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues .
- The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated.
- Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate.
- DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p < 0.001).
- EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p < 0.001).
- Conditions
- Rheumatic Heart Disease, Heart Failure
- Being tested
- SGLT2 inhibitor
- Medical subject headings
- Rheumatic Heart Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called gliflozins
case control study in which group will receive SGLT2I and group will not , to detect impact of the drug in changing NYHA class for heart failure and echographic parameter
| Study group | Role | What they receive |
|---|---|---|
| SGLT2I Group | the case group that will receive SGLT2I in the treatment Receives: Drug: SGLT2 inhibitor | |
| non - SGLT2I Group | the control group that will not receive SGLT2I in the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the clinical condition
improving or worsening in NYHA class: I- Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations.
II- Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina.
III- Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina.
IV- Symptoms occur at rest; any physical activity increases discomfort.
Measured: 6 months up to 1 year
change of the function and regurge
improving or worsening in echocardiographic parameter :
- ejection fraction by simpson methods
- severity of regurge by color Doppler and continuous wave Doppler
Measured: 6 months up to 1 year
Secondary outcomes (3)
major adverse cardiovascular event
monitor rate for Cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for HF between 2 groups
Measured: 6 months up to 1 year
Glomerular filtration rate affection
monitor rate of decline in the estimated glomerular filtration rate between 2 groups
Measured: 6 months up to 1 year
urinary tract infection
incidence of urinary tract infection between 2 groups by following urine analysis
Measured: 6 months up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Youssef Dandrawy, Assiut University
- Investigators
- Doaa A Fouad, MD, Study director, Assiut UniversityMagdy A Algowhary, MD, Study director, Assiut UniversityAhmed G Bakry, MD, Study director, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097585
- Sponsor's protocol ID
- gliflozins on rheumatic HF
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
PubMed 24491689Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
PubMed 32865377Inzucchi SE, Zinman B, Wanner C, Ferrari R, Fitchett D, Hantel S, Espadero RM, Woerle HJ, Broedl UC, Johansen OE. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vasc Dis Res. 2015 Mar;12(2):90-100. doi: 10.1177/1479164114559852. Epub 2015 Jan 14.
PubMed 25589482Chilton R, Tikkanen I, Cannon CP, Crowe S, Woerle HJ, Broedl UC, Johansen OE. Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes. Diabetes Obes Metab. 2015 Dec;17(12):1180-93. doi: 10.1111/dom.12572. Epub 2015 Oct 9.
PubMed 26343814Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.
PubMed 30586757Zuhlke LJ, Beaton A, Engel ME, Hugo-Hamman CT, Karthikeyan G, Katzenellenbogen JM, Ntusi N, Ralph AP, Saxena A, Smeesters PR, Watkins D, Zilla P, Carapetis J. Group A Streptococcus, Acute Rheumatic Fever and Rheumatic Heart Disease: Epidemiology and Clinical Considerations. Curr Treat Options Cardiovasc Med. 2017 Feb;19(2):15. doi: 10.1007/s11936-017-0513-y.
PubMed 28285457Carapetis JR, Beaton A, Cunningham MW, Guilherme L, Karthikeyan G, Mayosi BM, Sable C, Steer A, Wilson N, Wyber R, Zuhlke L. Acute rheumatic fever and rheumatic heart disease. Nat Rev Dis Primers. 2016 Jan 14;2:15084. doi: 10.1038/nrdp.2015.84.
PubMed 27188830McMurray 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 31535829
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gliflozins on Heart Failure Due to Regurgitant Rheumatic Valve Disease
- ClinicalTrials.gov ID
- NCT06097585
- Acronym / sponsor ID
- gliflozins on rheumatic HF
- Conditions
- Rheumatic Heart Disease, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 24 Oct 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.
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
Detailed description
- Rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group A β hemolytic Streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. Damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. Complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation .
- Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues .
- The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated.
- Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate.
- DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p < 0.001).
- EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p < 0.001).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2I Group | – | Drug: SGLT2 inhibitorthe case group that will receive SGLT2I in the treatment |
| non - SGLT2I Group | – | –the control group that will not receive SGLT2I in the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending outpatient clinic, cardiology department, Assiut university hospital and south valley university hospital
Key inclusion criteria (4 listed)
- All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion
- Patients aged 18 years or older at time of inclusion in the study
- Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
- Body Mass Index (BMI) < 45 kg/m2
Key exclusion criteria (6 listed)
- Advanced stage liver and kidney failure (glomerular filtration rate < 20 mL/min/1.73 m2).
- Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD)
- Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,…..etc within the 12 months prior to Visit 1
- Known allergy or hypersensitivity to SGLT-2 inhibitors
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
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 inhibitorAlso: gliflozinscase control study in which group will receive SGLT2I and group will not , to detect impact of the drug in changing NYHA class for heart failure and echographic parameter | Drug | SGLT2I Group |
Primary outcome
Change of the clinical condition
Time frame: 6 months up to 1 year
improving or worsening in NYHA class: I- Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations. II- Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. III- Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. IV- Symptoms occur at rest; any physical activity increases discomfort.
change of the function and regurge
Time frame: 6 months up to 1 year
improving or worsening in echocardiographic parameter : * ejection fraction by simpson methods * severity of regurge by color Doppler and continuous wave Doppler
3 secondary outcomes
major adverse cardiovascular event
Time frame: 6 months up to 1 year
Glomerular filtration rate affection
Time frame: 6 months up to 1 year
urinary tract infection
Time frame: 6 months up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Background: PubMed 24491689Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
- Background: PubMed 32865377Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
- Background: PubMed 25589482Inzucchi SE, Zinman B, Wanner C, Ferrari R, Fitchett D, Hantel S, Espadero RM, Woerle HJ, Broedl UC, Johansen OE. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vasc Dis Res. 2015 Mar;12(2):90-100. doi: 10.1177/1479164114559852. Epub 2015 Jan 14.
- Background: PubMed 26343814Chilton R, Tikkanen I, Cannon CP, Crowe S, Woerle HJ, Broedl UC, Johansen OE. Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes. Diabetes Obes Metab. 2015 Dec;17(12):1180-93. doi: 10.1111/dom.12572. Epub 2015 Oct 9.
- Background: PubMed 30586757Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.
- Background: PubMed 28285457Zuhlke LJ, Beaton A, Engel ME, Hugo-Hamman CT, Karthikeyan G, Katzenellenbogen JM, Ntusi N, Ralph AP, Saxena A, Smeesters PR, Watkins D, Zilla P, Carapetis J. Group A Streptococcus, Acute Rheumatic Fever and Rheumatic Heart Disease: Epidemiology and Clinical Considerations. Curr Treat Options Cardiovasc Med. 2017 Feb;19(2):15. doi: 10.1007/s11936-017-0513-y.
- Background: PubMed 27188830Carapetis JR, Beaton A, Cunningham MW, Guilherme L, Karthikeyan G, Mayosi BM, Sable C, Steer A, Wilson N, Wyber R, Zuhlke L. Acute rheumatic fever and rheumatic heart disease. Nat Rev Dis Primers. 2016 Jan 14;2:15084. doi: 10.1038/nrdp.2015.84.
- 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.
- 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.
Doaa A Fouad, MD study director
Assiut University
Magdy A Algowhary, MD study director
Assiut University
Ahmed G Bakry, MD study director
South Valley University
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease and Heart Failure, 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 4 inclusion and 6 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 30 Oct 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 Ahmed Y Dandrawy, Bachelor (+201013086863, ahmed_youssef200@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the clinical condition (time frame: 6 months up to 1 year). 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 NCT06097585, which also lists 8 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 30 Oct 2023.