替米沙坦与依那普利治疗射血分数降低的心力衰竭合并轻度肾功能损害患者的随机对照试验：“TRIUMF试验”
Telmisartan versus EnalapRil In heart failure with redUced ejection fraction patients with Moderately impaired kidney Functions; randomized controlled trial: "TRIUMF trial".
作者信息
Samir Ahmad, Aboel-Naga Salma, Shehata Ahmed, Abdelhamid Magdy
机构信息
Faculty of Medicine, Cairo University, Cairo, Egypt.
出版信息
Egypt Heart J. 2023 Aug 8;75(1):68. doi: 10.1186/s43044-023-00398-7.
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).
背景
射血分数降低的心力衰竭（HFrEF）与慢性肾脏病（CKD）并存时，肾素-血管紧张素-醛固酮系统抑制剂（RAASi）常因担心肾功能恶化（WRF）而未得到充分利用。替米沙坦是一种具有良好肾脏特性的RAASi，尽管其在HFrEF中的应用数据有限。本研究旨在比较替米沙坦与依那普利在HFrEF和CKD患者中的疗效和耐受性。
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 - 80毫克）或依那普利（5 - 40毫克）两组。在3个月和6个月时比较达到的RAASi剂量、剂量减少（DR）或停药（DC）、死亡/心力衰竭再住院（HFH）、纽约心脏协会（NYHA）分级和6分钟步行试验（6MWT）。在3个月和6个月时，替米沙坦组与依那普利组分别有93.5%对vs于68.6%以及95.2%对vs于72.9%的患者维持在目标剂量的≥50%。尽管在3个月和6个月时替米沙坦组达到的剂量更高，但与依那普利相比，替米沙坦导致的WRF更少（6.4%对vs 22.9%，p = 0.022；7.3%对vs 13.6%，p = 0.28），DR - DC发作次数也更少（31.9%对vs 55.1%，p = 0.018；35.7%对vs 56.5%，p = 0.041）。到研究结束时，每组有5例死亡，然而，HFH发生率在替米沙坦组和依那普利组分别为34.1%对vs 55.3%，p = 0.035，NYHA分级变化在替米沙坦组和依那普利组分别为-1[-2, 0]对vs 0[-1, 1]，p = 0.017。组内结果显示替米沙坦组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，与依那普利相比，替米沙坦在剂量滴定方面耐受性更好，导致的WRF更少，HFH更少，并且功能改善更明显。临床试验注册本研究已在clinicaltrials.gov上进行前瞻性注册，注册号为（NCT04736329）。
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