Dapagliflozin in Mangement of Pulmonary Hypertension Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2026-10-10

Brief Summary

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

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Detailed Description

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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\&#39;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

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Dapagliflozin (Forxiga)

Intervention Type DRUG

we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

Interventions

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Dapagliflozin (Forxiga)

we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

Intervention Type DRUG

Eligibility Criteria

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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 \&lt; 95 mmHg)
2. impaired renal function (eGFR \&lt; 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \&gt; 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

Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No