Gliflozins on HF in Regurgitant Rheumatic Heart

October 27, 2023 updated by: Ahmed Youssef Dandrawy, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SGLT2I Group
the case group that will receive SGLT2I in the treatment
Drug: SGLT2 inhibitor
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
Other Names:
  • gliflozins
non - SGLT2I Group
the control group that will not receive SGLT2I in the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months up to 1 year
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
6 months up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiovascular event
Time Frame: 6 months up to 1 year
monitor rate for Cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for HF between 2 groups
6 months up to 1 year
Glomerular filtration rate affection
Time Frame: 6 months up to 1 year
monitor rate of decline in the estimated glomerular filtration rate between 2 groups
6 months up to 1 year
urinary tract infection
Time Frame: 6 months up to 1 year
incidence of urinary tract infection between 2 groups by following urine analysis
6 months up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Doaa A Fouad, MD, Assiut University
  • Study Director: Magdy A Algowhary, MD, Assiut University
  • Study Director: Ahmed G Bakry, MD, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

September 30, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gliflozins on rheumatic HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on SGLT2 inhibitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe