Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Oral Tolvaptan on Left Ventricular Dilation and Function in Patients With Heart Failure and Systolic Dysfunction

Udelson, James E.; McGrew, Frank; Flores, Enrique; Ibrahim, Hassan; Katz, Stewart; Koshkarian, Gregory M.; O’Brien, Terrence X.; Kronenberg, Marvin W.; Zimmer, Christopher; Orlandi, Cesare; Konstam, Marvin A.

doi:10.1016/j.jacc.2007.01.091

Cited by 148 publications

(122 citation statements)

References 33 publications

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“…6) Tolvaptan is a vasopressin type 2 receptor antagonist that is effective in patients with HF. [7][8][9][10][11][12][13][14] Tolvaptan became available in Japan for the treatment of HF in 2010. When sufficient diuresis is not achieved with diuretics such as loop diuretics, tolvaptan is recommended.…”

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confidence: 99%

Effects of Tolvaptan With or Without the Pre-Administration of Renin-Angiotensin System Blockers in Hospitalized Patients With Acute Decompensated Heart Failure

et al. 2017

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SummaryWe examined whether tolvaptan combined with an angiotensin II receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACE-I) is more effective than tolvaptan alone in the treatment of patients with heart failure (HF). Sixty-five hospitalized patients with acute decompensated HF were included in this study. They were divided into 2 groups; an ARB/ACE-I group (n = 44, who received ARB or ACE-I before the use of tolvaptan) and a non-ARB/ACE-I group (n = 21). There were no significant differences in patient characteristics including medications at baseline between the non-ARB/ACE-I and ARB/ACE-I groups with the exception of the percentages of hypertension and ischemic heart disease. Urinary volume (UV) at baseline in the ARB/ACE-I group was slightly higher than that in the non-ARB/ACE-I group. The increase in UV after the use of tolvaptan in the non-ARB/ACE-I group was significantly higher than that in the ARB/ACE-I group. The cardiothoracic ratio and the reduction in body weight were similar between the groups after tolvaptan use. Finally, in a logistic regression analysis, a response to the use of tolvaptan was independently associated with the non-use of ARB/ACE-I, but not with age, gender, body mass index, loop diuretic, or human arterial natriuretic peptide. In conclusion, tolvaptan alone might induce an increase in UV in decompensated HF patients without ARB/ ACE-I, although the treatment of HF with ARB/ACE-I is the first choice strategy. (Int Heart J 2017; 58: 385-392)

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Effects of Tolvaptan With or Without the Pre-Administration of Renin-Angiotensin System Blockers in Hospitalized Patients With Acute Decompensated Heart Failure

et al. 2017

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“…[1][2][3][4][5][6][7][8][9] High age and chronic kidney disease are known risk factors of refractoriness to TLV, [10][11][12] whereas preserved function of the renal collecting duct, which is confirmed by a higher level of urine aquaporin-2 (U-AQP2) relative to plasma AVP (P-AVP), is a predictor of responses to TLV. 13) Responders seem to experience not only an improved clinical course but also better prognosis during TLV treatment compared with those not receiving TLV.…”

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confidence: 99%

Tolvaptan Improves the Long-Term Prognosis in Patients With Congestive Heart Failure With Preserved Ejection Fraction as Well as in Those With Reduced Ejection Fraction

Imamura

Kinugawa

2016

Int. Heart J.

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SummaryTolvaptan (TLV), an arginine vasopressin type 2 antagonist, has been shown to play a role in ameliorating symptomatic congestion and normalizing diluted hyponatremia in patients with congestive heart failure (HF). However, most evidence was derived from patients with HF with reduced ejection fraction (HFrEF), and the clinical efficacy of TLV in patients with HF with preserved ejection fraction (HFpEF) remains uncertain. In this study, we retrospectively enrolled 60 in-hospital patients with stage D HF, who had received TLV to treat symptomatic congestion at our institute between 2011 and 2013. As a control group, we also enrolled 60 background-matched HF patients who did not receive TLV therapy. Patients with HFpEF (n = 29), whose left ventricular ejection fraction was > 45%, had higher age and a lower urine aquaporin-2 level relative to the plasma arginine vasopressin concentration compared with those with HFrEF (n = 91). TLV therapy significantly reduced the 2-year readmission rates in both the HFrEF and HFpEF populations (P < 0.05 for both), indicating that TLV therapy may improve the long-term prognosis not only in patients with HFrEF but also in those with HFpEF. (Int Heart J 2016; 57: 600-606)

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“…15) However, it has been also demonstrated that administration of tolvaptan was not associated with increases in systolic vascular resistance nor progression of left ventricular remodeling. 11,16) Considering these results, increases in AVP after administration of tolvaptan may be too trivial to significantly stimulate V1a receptors. The preserved blood pressure observed in our study may have resulted from mobilization of free water from the third space into the vascular space due to increased serum osmolality.…”

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confidence: 99%

Correction of Hyponatremia by Tolvaptan Before Left Ventricular Assist Device Implantation

et al. 2012

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SummaryHypervolemic hyponatremia is often complicated with advanced heart failure together with increased excretion of sodium by diuretics. Tolvaptan, an oral vasopressin-2-receptor antagonist, has been previously reported to improve congestion and correct hyponatremia through increased excretion of free water. However, there is little evidence concerning the administration of tolvaptan in patients with stage D heart failure. We experienced 2 patients with stage D heart failure who received 3.75 mg/day of tolvaptan to correct hyponatremia before ventricular assist device implantation. It may be useful, even for patients with stage D heart failure, to administer a low dose of tolvaptan to treat hyponatremia before ventricular assist device implantation to avoid a drastic alteration in serum sodium concentration perioperatively. (Int Heart J 2012; 53: 391-393) Key words: Osmotic demyelination syndrome, Arginine vasopression, Heart failure H yponatremia, which is generally defined as serum sodium of < 135 mEq/L, 1) is a common electrolyte disorder among hospitalized patients and is associated with increased mortality.2) In patients with congestive heart failure, hypervolemic hyponatremia results from water retention, by way of increases in arginine vasopression (AVP) levels and/or decreases in glomerular filtration.3) In patients with stage D heart failure in particular, almost all patients cannot help depending on diuretics, which facilitate hyponatremia due to increased excretion of sodium and stimulation of renin/angiotensin and norepinephrine secretion as well as inappropriate AVP secretion against low or normal serum osmolality. 4) We here experienced 2 patients with stage D heart failure, who were in progressive decline with severe hyponatremia despite optimal medication and intravenous catecholamine infusion. Since both patients were indicated for left ventricular assist device (LVAD) implantation, we were afraid that osmotic demyelination syndrome (ODS) would emerge after rapid correction of hyponatremia through stabilization of hemodynamic state after surgery. 5) To avoid this, we administered 3.75 mg/day of tolvaptan, an oral vasopressin-2-receptor antagonist, to treat their hyponatremia preoperatively. Case ReportThe first patient was a 33-year-old male with dilated cardiomyopathy (DCM) (Figure 1, Table). He became dependent upon intravenous dobutamine in August 2010 despite administration of maximum medical therapy including pimobendan, carvedilol, furosemide, spironolactone, and enalapril. Cardiac resynchronization therapy with a defibrillator could not help worsening of his heart failure and he was transferred to our hospital to consider VAD therapy in January 2011. His serum sodium level was 123 mEq/L, serum creatinine level was 0.81 mg/dL, and B-type natriuretic peptide level was 1707 pg/mL on his admission. Right catheterization showed that mean right atrial (RA) pressure was 12 mmHg, left ventricular end-diastolic pressure was 38 mmHg, and cardiac index (CI) was 1.7 L/ minute/m 2 . Administrat...

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Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Oral Tolvaptan on Left Ventricular Dilation and Function in Patients With Heart Failure and Systolic Dysfunction

Cited by 148 publications

References 33 publications

Effects of Tolvaptan With or Without the Pre-Administration of Renin-Angiotensin System Blockers in Hospitalized Patients With Acute Decompensated Heart Failure

Effects of Tolvaptan With or Without the Pre-Administration of Renin-Angiotensin System Blockers in Hospitalized Patients With Acute Decompensated Heart Failure

Tolvaptan Improves the Long-Term Prognosis in Patients With Congestive Heart Failure With Preserved Ejection Fraction as Well as in Those With Reduced Ejection Fraction

Correction of Hyponatremia by Tolvaptan Before Left Ventricular Assist Device Implantation

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