ID
11971
Description
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
Mots-clés
Versions (3)
- 11/12/2013 11/12/2013 - Martin Dugas
- 07/08/2014 07/08/2014 - Martin Dugas
- 27/08/2015 27/08/2015 - Martin Dugas
Téléchargé le
27 août 2015
DOI
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Licence
Creative Commons BY-NC 3.0 Legacy
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Eligibility Heart Failure EVEREST NCT00071331
Eligibility Heart Failure EVEREST NCT00071331
- StudyEvent: Eligibility
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
Contraception failure
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009866
Description
Pregnant
Type de données
boolean
Alias
- UMLS CUI [1]
- C0549206
Description
Inability for consent
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1299582
Description
Cardiac surgery
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018821
Description
Planned cardiac procedures
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1279986
- UMLS CUI [1,2]
- C1301732
Description
Cardiac mechanical support
Type de données
boolean
Alias
- UMLS CUI [1]
- C0457617
Description
Bi-ventricular pacer
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0030163
- UMLS CUI [1,2]
- C0699808
Description
Life expectancy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023671
Description
Myocardial infarction
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027051
Description
Ventricular arrhythmia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085612
Description
Stroke
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038454
Description
Cardiac valvular disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018824
Description
Hypertrophic cardiomyopathy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007194
Description
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0040128
- UMLS CUI [2]
- C0238294
- UMLS CUI [3]
- C0268407
Description
Multiple Sclerosis | Stroke
Type de données
boolean
Alias
- UMLS CUI [1]
- C0026769
- UMLS CUI [2]
- C0038454
Description
Liver disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085605
Description
Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Obesity
Type de données
boolean
Alias
- UMLS CUI [1]
- C0028754
Description
Systolic blood pressure
Type de données
boolean
Alias
- UMLS CUI [1]
- C0871470
Description
Serum creatinine
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201976
Description
Serum potassium
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202194
Description
Hemoglobin
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518015
Description
Hypersensitivity to benzazepine
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0005034
Description
Drug or alcohol abuse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0237123
Description
Inability to take oral medications
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3839225
Description
Other trial
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Other tolvaptan trial
Type de données
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])