背景:当射血分数降低的心力衰竭(HFrEF)和慢性肾脏疾病(CKD)并存时,由于担心肾功能恶化(WRF),肾素血管紧张素-醛固酮系统抑制剂(RAASi)通常未得到充分利用。替米沙坦是一个良好的肾脏特征的RAASi,尽管其在HFrEF中的效用数据有限。本研究旨在比较替米沙坦与依那普利对HFrEF和CKD患者的疗效和耐受性。
结果:本研究将107例HFrEF和CKD患者随机分为每日服用替米沙坦(10-80mg)或依那普利(5-40mg)。达到的RAASi剂量,剂量减少(DR)或不连续(DC),死亡/心力衰竭再住院(HFH),在3个月和6个月时比较NYHA等级和6MWT。在3个月和6个月时,在替米沙坦和依那普利组中,93.5%对68.6%和95.2%对72.9%维持≥50%的目标剂量。分别。尽管在3个月和6个月时达到了更高的剂量,替米沙坦与依那普利相比,WRF较低(6.4%与22.9%,p=0.022和7.3%与13.6%,p=0.28)和更少的DR-DC发作(31.9%与55.1%,p=0.018和35.7%vs.56.5%,p=0.041),分别。在研究结束时,每组有5人死亡,然而,HFH发生率分别为34.1%和55.3%,p=0.035,NYHA等级变化为-1[-2,0]对0[-1,1],泰米沙坦与依那普利患者的p=0.017,分别。组内结果显示Telmisartan-的6MWT有所改善,依那普利组利尿剂需求增加。
结论:在HFrEF和CKD患者中,替米沙坦对上调的耐受性更好,导致较少的WRF,与依那普利相比,HFH更少,功能改善更好。临床试验注册这项研究在临床试验中进行了前瞻性注册。注册号(NCT04736329)。
BACKGROUND: When heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD) co-exist, Renin angiotensin-aldosterone system inhibitors (RAASi) are often underutilized for the fear of worsening renal function (WRF). Telmisartan is a RAASi characteristic for a favorable renal profile, although data on its utility in HFrEF is limited. This
study aimed to compare efficacy and tolerability of Telmisartan versus
Enalapril in patients with HFrEF and CKD.
RESULTS: This
study randomized 107 patients with HFrEF and CKD to either Telmisartan (10-80 mg) or
Enalapril (5-40 mg) daily. The achieved RAASi dose, dose reductions (DR) or dis-continuation (DC), death/Heart failure rehospitalization (HFH), NYHA class and 6MWT were compared at 3- and 6-months. At 3- and 6-months, 93.5% versus 68.6% and 95.2% versus 72.9% were maintaining ≥ 50% of the target dose in the Telmisartan- versus Enalapril-group, respectively. Despite the higher achieved dose by 3- and 6-months, Telmisartan versus Enalapril was associated with less WRF (6.4% vs. 22.9%, p = 0.022 and 7.3% vs. 13.6%, p = 0.28) and fewer episodes of DR-DC (31.9% vs. 55.1%, p = 0.018 and 35.7% vs. 56.5%, p = 0.041), respectively. By the end of the
study, there were 5 deaths in each group, yet, HFH occurred in 34.1% versus 55.3%, p = 0.035, and NYHA class changed by - 1 [- 2, 0] versus 0 [- 1, 1], p = 0.017 in Telmisartan- versus Enalapril patients, respectively. Within-group results showed improvement in 6MWT in Telmisartan-, and increase in diuretic requirements in Enalapril-group.
CONCLUSIONS: In patients with HFrEF and CKD, Telmisartan was better tolerated to uptitrate, caused less WRF, less HFH and showed better functional improvement compared to Enalapril. Clinical
trial registration This
study was prospectively registered on clinicaltrials.gov, with registration number (NCT04736329).