Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612086
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Dapagliflozin in Mangement of Patients with Pulmonary Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Dapagliflozin in Mangement of Patients with Pulmonary Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effect of SGLT2 Dapagliflozinon prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital
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 PHamp39s 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None