ID
11971
Beschrijving
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan Inclusion Criteria: - Age greater than or equal to 18 years - Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization. The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea. - NYHA Class III or IV at the time of hospitalization. - Left Ventricular Ejection Fraction <= 40% within one year Exclusion Criteria - Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form - Positive urine pregnancy test - Inability to provide written informed consent - Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions - Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment - Subjects who are on cardiac mechanical support - History of bi-ventricular pacer placement within the last 60 days - Co-morbid condition with an expected survival less than six months - Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization - History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator - History of a cerebrovascular accident within the last 30 days - Hemodynamically significant uncorrected primary cardiac valvular disease - Hypertrophic cardiomyopathy (obstructive or non-obstructive) - CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy - Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes - History of primary significant liver disease or acute hepatic failure, as defined by the investigator - History of poorly controlled diabetes mellitus - Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40 - Supine systolic arterial blood pressure < 90 mmHg - Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L - Serum potassium > 5.5 mEq/L or > 5.5 mmol/L - Hemoglobin < 9 g/dL or < 90 g/L - History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril) - History of drug or medication abuse within the past year, or current alcohol abuse - Inability to take oral medications - Participation in another clinical drug or device trial within the past 30 days - Previous participation in this or any other tolvaptan clinical trial
Trefwoorden
Versies (3)
- 11-12-13 11-12-13 - Martin Dugas
- 07-08-14 07-08-14 - Martin Dugas
- 27-08-15 27-08-15 - Martin Dugas
Geüploaded op
27 augustus 2015
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
Model Commentaren :
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Eligibility Heart Failure EVEREST NCT00071331
Eligibility Heart Failure EVEREST NCT00071331
- StudyEvent: Eligibility
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Contraception failure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009866
Beschrijving
Pregnant
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549206
Beschrijving
Inability for consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1299582
Beschrijving
Cardiac surgery
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018821
Beschrijving
Planned cardiac procedures
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1279986
- UMLS CUI [1,2]
- C1301732
Beschrijving
Cardiac mechanical support
Datatype
boolean
Alias
- UMLS CUI [1]
- C0457617
Beschrijving
Bi-ventricular pacer
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030163
- UMLS CUI [1,2]
- C0699808
Beschrijving
Life expectancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023671
Beschrijving
Myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Ventricular arrhythmia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085612
Beschrijving
Stroke
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038454
Beschrijving
Cardiac valvular disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018824
Beschrijving
Hypertrophic cardiomyopathy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007194
Beschrijving
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040128
- UMLS CUI [2]
- C0238294
- UMLS CUI [3]
- C0268407
Beschrijving
Multiple Sclerosis | Stroke
Datatype
boolean
Alias
- UMLS CUI [1]
- C0026769
- UMLS CUI [2]
- C0038454
Beschrijving
Liver disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085605
Beschrijving
Diabetes mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschrijving
Obesity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0028754
Beschrijving
Systolic blood pressure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Serum creatinine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Serum potassium
Datatype
boolean
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Hemoglobin
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Hypersensitivity to benzazepine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0005034
Beschrijving
Drug or alcohol abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0237123
Beschrijving
Inability to take oral medications
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3839225
Beschrijving
Other trial
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Other tolvaptan trial
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1176308
Similar models
Eligibility Heart Failure EVEREST NCT00071331
- StudyEvent: Eligibility
C1319796 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C0699808 (UMLS CUI [1,2])
C0238294 (UMLS CUI [2])
C0268407 (UMLS CUI [3])
C0038454 (UMLS CUI [2])
C0005034 (UMLS CUI [1,2])
C1176308 (UMLS CUI [1,2])