PMID- 30255476 OWN - NLM STAT- MEDLINE DCOM- 20190617 LR - 20190617 IS - 1179-187X (Electronic) IS - 1175-3277 (Linking) VI - 19 IP - 2 DP - 2019 Apr TI - Short-Term Effects of Tolvaptan in Tricuspid Insufficiency Combined with Left Heart Valve Replacement-Caused Volume-Overload Patients: Results of a Prospective Pilot Study. PG - 211-218 LID - 10.1007/s40256-018-0304-1 [doi] AB - OBJECTIVES: Our objective was to explore the effects of tolvaptan as a new therapeutic approach in patients with right heart failure with tricuspid insufficiency (TI). METHODS: This prospective, multicenter, non-randomized controlled pilot study enrolled patients (N = 40) with TI from the Shanghai Chest Hospital and Shanghai Tongren Hospital who fulfilled inclusion criteria between March 2015 and June 2016. Participants were assigned to receive either tolvaptan combined with torasemide (n = 20) or torasemide monotherapy (n = 20; control group). The primary endpoints were changes in patient weight and in tricuspid annular plane systolic excursion (TAPSE) after 10 days of treatment. The secondary endpoints included net fluid balance and cardiac functions before and after medication from the first to the tenth day of treatment. Safety was evaluated by monitoring adverse and serious adverse events. RESULTS: TAPSE significantly increased in the tolvaptan group compared with the control group after 10 days of medication (P = 0.029). Daily weight losses in the tolvaptan group significantly increased as the time of treatment increased (time x group, P = 0.022). Recovery to New York Heart Association (NYHA) grade I occurred 4 days earlier in the tolvaptan group. In addition, the net fluid balance and median net fluid balance were significantly higher in the tolvaptan group. Eight adverse events and one serious adverse event were recorded in the tolvaptan group and 15 adverse events were recorded in the control group. CONCLUSIONS: Our results indicate that tolvaptan might be a useful and safe drug to improve heart function in patients with right heart failure with TI after left heart valve replacement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT02644616. FAU - Yuan, Fang AU - Yuan F AD - Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. FAU - Wu, Zhangmin AU - Wu Z AD - Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. FAU - Jiang, Li AU - Jiang L AD - Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. jiangli@shtrhospital.com. FAU - Zhou, Jun AU - Zhou J AD - Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. FAU - Xu, Lei AU - Xu L AD - Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, 200030, China. FAU - Liu, Hua AU - Liu H AD - Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, 200030, China. FAU - Ma, Lan AU - Ma L AD - Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, 200030, China. FAU - Zhai, Zhenzhou AU - Zhai Z AD - Department of Emergency, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. FAU - Zhang, Junjie AU - Zhang J AD - Department of Emergency, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200336, China. LA - eng SI - ClinicalTrials.gov/NCT02644616 GR - 20162002/Acute Heart Failure Specialist/ PT - Journal Article PT - Multicenter Study PL - New Zealand TA - Am J Cardiovasc Drugs JT - American journal of cardiovascular drugs : drugs, devices, and other interventions JID - 100967755 RN - 0 (Antidiuretic Hormone Receptor Antagonists) RN - 0 (Diuretics) RN - 21G72T1950 (Tolvaptan) RN - W31X2H97FB (Torsemide) SB - IM MH - Aged MH - Antidiuretic Hormone Receptor Antagonists/adverse effects/*therapeutic use MH - Diuretics/adverse effects/therapeutic use MH - Female MH - Heart Valve Diseases/etiology/physiopathology MH - Heart Valve Prosthesis Implantation/*adverse effects MH - Humans MH - Male MH - Middle Aged MH - Pilot Projects MH - Prospective Studies MH - Tolvaptan/adverse effects/*therapeutic use MH - Torsemide/adverse effects/therapeutic use MH - Treatment Outcome MH - Tricuspid Valve/drug effects/physiopathology MH - Tricuspid Valve Insufficiency/complications/*drug therapy/physiopathology MH - Water-Electrolyte Balance/drug effects EDAT- 2018/09/27 06:00 MHDA- 2019/06/18 06:00 CRDT- 2018/09/27 06:00 PHST- 2018/09/27 06:00 [pubmed] PHST- 2019/06/18 06:00 [medline] PHST- 2018/09/27 06:00 [entrez] AID - 10.1007/s40256-018-0304-1 [pii] AID - 10.1007/s40256-018-0304-1 [doi] PST - ppublish SO - Am J Cardiovasc Drugs. 2019 Apr;19(2):211-218. doi: 10.1007/s40256-018-0304-1.