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The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease: A multicenter, randomized, open label, blind endpoint study (AQUAKID-Study)

Phase 4
Recruiting
Conditions
congestive heart failure and chronic kidney disease
Registration Number
JPRN-UMIN000012006
Lead Sponsor
Fujita Health University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who recently started undergoing hemodialysis 2.Patients treated with the following drugs during the initial eligibility assessment period (a)Phosphodiesterase III inhibitors (amrinone, milinone, or loprinone) (b)Catecholamines (c)Colforsins 3.Acute renal failure 4.Hypernatremia, Na levels ≥147 mEq/dL 5.Patients unable to sense thirst or those with difficulty drinking water 6.Anuria 7.Patients with malignancy, including multiple myeloma or primary amyloidosis 8.Patients suspected of having loss of circulating plasma volume or patients with hypotension 9.Severe aortic stenosis or severe dilated cardiomyopathy 10.Acute coronary syndrome 11.Recent myocardial infarction, percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) within the past 3 months 12.Patients scheduled for PCI or CABG 13.Stroke within the past 3 months 14.Severe neuropsychological deficit 15.Severe liver damage or hepatic coma 16.Severe obstructive and/or restrictive lung disease 17.Severe pulmonary hypertension 18.Patients with other life-threatening illnesses 19.Pregnant women 20.Allergy to tolvaptan 21.Others deemed ineligible for this trial by physicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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