Dapagliflozin in Mangement of Pulmonary Hypertension Patients

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Pulmonary Hypertension

Treatments: Drug: Dapagliflozin (Forxiga)

Study type: Interventional

Funder types: Other

Identifiers

NCT06612086

Dapagliflozin in PH

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

we follow up patient who take Dapagliflozin in patient with pulmonary hypertension

Experimental group

Description:

we follow up patient who take Dapagliflozin in patient with pulmonary hypertension

Treatment:

Drug: Dapagliflozin (Forxiga)