ID
11971
Beschreibung
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
Stichworte
Versionen (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
Hochgeladen am
27. August 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Eligibility Heart Failure EVEREST NCT00071331
Eligibility Heart Failure EVEREST NCT00071331
- StudyEvent: Eligibility
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Contraception failure
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009866
Beschreibung
Pregnant
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549206
Beschreibung
Inability for consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1299582
Beschreibung
Cardiac surgery
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018821
Beschreibung
Planned cardiac procedures
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1279986
- UMLS CUI [1,2]
- C1301732
Beschreibung
Cardiac mechanical support
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457617
Beschreibung
Bi-ventricular pacer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030163
- UMLS CUI [1,2]
- C0699808
Beschreibung
Life expectancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023671
Beschreibung
Myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Ventricular arrhythmia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085612
Beschreibung
Stroke
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038454
Beschreibung
Cardiac valvular disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018824
Beschreibung
Hypertrophic cardiomyopathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007194
Beschreibung
Thyroid disease, active myocarditis or amyloid cardiomyopathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040128
- UMLS CUI [2]
- C0238294
- UMLS CUI [3]
- C0268407
Beschreibung
Multiple Sclerosis | Stroke
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0026769
- UMLS CUI [2]
- C0038454
Beschreibung
Liver disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085605
Beschreibung
Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
Obesity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0028754
Beschreibung
Systolic blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Serum creatinine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Serum potassium
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Hemoglobin
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518015
Beschreibung
Hypersensitivity to benzazepine
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0005034
Beschreibung
Drug or alcohol abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0237123
Beschreibung
Inability to take oral medications
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3839225
Beschreibung
Other trial
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Other tolvaptan trial
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1176308
Ähnliche Modelle
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])