Dapagliflozin in Mangement of Pulmonary Hypertension Patients

October 25, 2024 updated by: wessam sherif shokry zaki, Assiut University

Role of Dapagliflozin in Mangement of Pulmonary Hypertension Patients

Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. It is clinically diagnosed by a resting mean pulmonary arterial pressure (mPAP) exceeding 20 mmHg . At present, PH's prevalence is approximated at 1 % of the global population and increases to 10 % for individuals over 65 years old, with considerable morbidity and mortality. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have emerged a metabolic dysfunction and exert cardioprotective effects. DELIVER randomized trials have shown that ( dapagliflozin) can reduce all-cause mortality and hospitalizations due to HF in patients with HF with a mildly reduced or preserved LV function .

The beneficial effects of SGLT2i on the left ventricular systolic and diastolic function, and functional symptom burden have been demonstrated in several studies, but not much is known about the effects of these drugs on the right ventricular (RV) systolic function . The RV is often neglected because of its complex anatomy and the difficulty of obtaining satisfactory imaging "windows" in daily practice . However, the RV has been shown to play an important prognostic role following cardiac surgery and in patients with HF, pulmonary arterial hypertension, or ischemic heart disease . In clinical practice, the assessment of the RV function is usually undertaken by measuring only the longitudinal systolic function, as reflected in the measurement of the tricuspid annular plane systolic excursion (TAPSE) and tricuspid lateral annular systolic velocity (s' wave) derived from Doppler tissue imaging. The fractional area change (FAC), on the other hand, gives us an insight into the radial contraction of the RV [8]. Because these parameters are load- and angle-dependent, advanced echocardiographic methods, such as speckle-tracking echocardiography (STE) measuring the longitudinal strain of the RV free wall (RV FWS) , have recently emerged as more accurate estimates of the RV systolic function . TAPSE and s' wave measure only the longitudinal RV function in the basal region of the RV free wall and were shown to be an independent predictor of cardiac death and major adverse cardiovascular events (MACE) in patients with diverse cardiovascular diseases. Furthermore, the ratio between the TAPSE and systolic pulmonary artery pressure (SPAP) represents the non-invasive measurement of the right ventriculo-arterial coupling and the RV contractile function.

For these reasons, Investigators designed the present study to investigate the effects of SGLT2 espacially dapagliflozin on the RV systolic function after it was added to optimal medical therapy (OMT) on the patient with pulmonary hypertension

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Egypt
      • Assuit, Egypt
        • Assiut University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older

Exclusion Criteria:

  1. symptomatic hypotension (systolic blood pressure < 95 mmHg)
  2. impaired renal function (eGFR < 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level > 5.2 mmol/L
  3. hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range
  4. biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)),
  5. the current use of hormone replacement therapy, chemotherapy, or immunotherapy
  6. Type 1 diabetes mellitus
  7. Acute pulmonary embolism (15)
  8. Signficant Primary valvular Heart disease
  9. Ischemic heart disease

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: we follow up patient who take Dapagliflozin in patient with pulmonary hypertension
Drug: Dapagliflozin (Forxiga)
we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain )
Time Frame: 6 month
patients with pulmonary hypertension , conventional parameters of RV systolic function, including TAPSE, FAC, s', and RVEF, may be normal despite abnormal RV strain, which is an additional reason for the usage of RV strain in these patients. RV longitudinal strain can identify subclinical RV dysfunction at the early phase of disease and may serve as an important marker of subtle RV systolic dysfunction when conventional parameters, primarily TAPSE, are in the normal range (25, 26).so investigator use RV strain to compare between RV function before and after taking of dapagliflozin
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Dapagliflozin on Quality of life for patient with pulmonary hypertension by Kansas City Cardiomyopathy Questionnaire Score
Time Frame: 6 month
Quality of the life by Kansas City Cardiomyopathy Questionnaire Score score assess quality of life of patient , investigator used score to compare quality of life before and after taking Dapagliflozin this score are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to100: good to excellent.
6 month

Collaborators and Investigators

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

Sponsor

Assiut 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)

October 25, 2024

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

September 21, 2024

First Submitted That Met QC Criteria

September 21, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dapagliflozin in PH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Subscribe