الفهرس 
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Abstract
SUMMARY
Heart failure (HF) is a worldwide progressive clinical syndrome in which there is impaired ventricular filling and/or reduced ejection of blood to the systemic circulation sufficient to meet the body’s tissues needs for oxygen and metabolism.
It is a leading cause of morbidity and mortality and it affects both males and females equally.
Most patients with Heart failure have symptoms and physical limitations due to impaired left ventricular myocardial function. These symptoms include dyspnea, decreased exercise tolerance and fluid retention which cause significant reduction in the patients’ quality of life. HF affects the quality of life much more than several other chronic diseases.
Treatment of HFrEF classically includes: diuretics, beta-blockers, angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitor, hydralazine plus nitrate, digoxin, and aldosterone antagonists which can produce an improvement in symptoms. On the other hand, prolongation of patient survival has been only documented with beta blockers, ACEIs, angiotensin receptor neprilysin inhibitor, hydralazine plus nitrate, and aldosterone antagonists. More limited evidence of survival benefit is available for diuretic therapy.
This study was designed to study the effects of dapapagliflozin 10 mg/day in and out of hospital compared with placebo on LV volumes and systolic function, functional capacity and quality of life and blood levels of NT pro-BNP amongpatients with HFrEF.
This was a randomized, single-blind, Placebo-controlled study, included 93 adult male and non-pregnant female patients with established diagnosis of heart failure, NYHA functional class II-IV and their left ventricular ejection fraction ≤ 40%. The study included a 1month screening period followed by 3 months of treatment phase including three arms. The first arm and second arm included dapagliflozin 10 mg/day in addition to appropriate treatment for heart failure; the first arm included group I = out of hospital patients (chronic compensated HF), the second arm group II = in hospital patients (acute decompensated HF). The third arm included placebo in addition to appropriate treatment for heart failure.
The main results of the study revealed that:
There was no statistical significant difference between study groups as regards age and sex distributions which indicated proper matching between groups.There was no statistical significant difference between study groups as regards medical history (smoking, DM, HTN, or IHD) which indicated proper matching between groups. Moreover; as regard baseline investigations and baseline echo; there was a statistically significant difference between group II and each of group I and group III in the baseline investigations and Echo results on the level of MLHFQ, LVEDV, and LVESV, with group II having a higher level. Regarding the level of NT pro-BNP, there was a statistically significant difference (p-value< 0.05) between group III and each of groups I and II, with group III having a lower level, group I’s mean of EF was statistically greater than group II’s and group III’s, respectively. In contrast, there was no statistically significant difference in the level of eGFR with a p-value >0.05.
There was a statistically significant difference between group II and each of group I and group III in the follow up investigations and Echo results on the level of LVEDV, and LVESV, with group II having a higher level. Regarding the level of NT pro-BNP, there was a statistically significant difference (p-value< 0.05) between group III and each of groups I and II, with group III having a lower level. With a p-value of <0.05, group I’s mean of MLHFQ , and EF was statistically lower level of MLHFQ and greater level of EF than group II’s and group III’s, respectively. In contrast, there was no statistically significant difference in the level of eGFR with a p-value >0.05.
It was revealed a statistically significant difference in the NYHA classifications degree between group II and each of groups I and III, with all group II cases being grade IV, with no difference between group I and group III (64.5%, and 61.3% respectively.
B-blockers, ACEI/ARB, and MRA medicines were used to treat every case in the three research groups.
As regard effect of dapagliflozin on investigations and Echo in group I cases with chronic compensated HF; the levels of NT pro-BNP, MLHFQ, LVEDV, and LVESV in group I’s follow-up were statistically significantly decreased. However, there was no statistically significant change in the EF level in the follow-up.
IN group II cases withacutenon-compensated HF; the levels of MLHFQ were decreased and level of LVEDV were increased in follow-up with a p-value <0.05. However, there was no statistically significant change in the NT pro-BNP level, LVESV, and EF level in the follow-up with a p-value > 0.05. While in group III ( placebo ) the levels of NT pro-BNP, and MLHFQ were decreased and level of EF were increased in follow-up with a p-value <0.05. However, there was no statistically significant change in the LVEDV and LVESV level in the follow-up with a p-value > 0.05. The level of LVEDV and LVESV were decreased in group I. However, there was no statistically significant change in the EF level in the follow-up with a p-value > 0.05.
For MLHFQ all three groups were differing from each other but the much decrease was in group I and II.
Based on our results we recommend for further studies on larger patients and longer period of follow up to emphasize our conclusion.