Gliflozins on HF in Regurgitant Rheumatic Heart

NCT06097585 | Unknown

• 1 other identifier: gliflozins on rheumatic HF
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease

Conditions

Rheumatic Heart Disease; Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  6 months up to 1 year

Secondary Outcomes (3)

• major adverse cardiovascular event

  6 months up to 1 year

• Glomerular filtration rate affection

  6 months up to 1 year

• urinary tract infection

  6 months up to 1 year

Study Arms (2)

SGLT2I Group

the case group that will receive SGLT2I in the treatment

Drug: SGLT2 inhibitor

non - SGLT2I Group

the control group that will not receive SGLT2I in the treatment

Interventions

SGLT2 inhibitor DRUG

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

Also known as: gliflozins

SGLT2I Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending outpatient clinic, cardiology department, Assiut university hospital and south valley university hospital

You may qualify if:

• All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion
• Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
• Body Mass Index (BMI) \< 45 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 24491689 BACKGROUND

• Packer 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.

  PMID: 32865377 BACKGROUND

• Inzucchi 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.

  PMID: 25589482 BACKGROUND

• Chilton 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.

  PMID: 26343814 BACKGROUND

• Fitchett 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.

  PMID: 30586757 BACKGROUND

• Zuhlke 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.

  PMID: 28285457 BACKGROUND

• Carapetis 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.

  PMID: 27188830 BACKGROUND

• McMurray 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.

  PMID: 31535829 BACKGROUND

MeSH Terms

Conditions

Rheumatic Heart Disease; Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Doaa A Fouad, MD

  Assiut University

  STUDY DIRECTOR

• Magdy A Algowhary, MD

  Assiut University

  STUDY DIRECTOR

• Ahmed G Bakry, MD

  South Valley University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Y Dandrawy, Bachelor

CONTACT

+201013086863; ahmed_youssef200@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 24, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10