EUCTR2012-003219-77-DK
Active, not recruiting
Phase 1
Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure
Copenhagen University Hospital, Rigshospitalet0 sites20 target enrollmentDecember 20, 2012
ConditionsHeart FailureMedDRA version: 14.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsVaprisol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Age \> 18 years
- •\-LVEF \< 45 %
- •\-Treatment with beta\-blockers and ACE\-inhibitors for at least 1 month
- •\-NYHA\-class II\-III
- •\-Given informed consent
- •Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will provide a negative urine HCG before entering the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 15
Exclusion Criteria
- •\-Signs of symptomatic or ongoing myocardial ischemia
- •\-Presence of hypovolemic hyponatremia (as judged by the investigator)
- •\-Clinical signs of volume depletion or dehydration
- •\-Hypernatremia (P\-Na\+) \> 145 mmol/L
- •\-Chronic obstructive pulmonary disease (FEV1 \< 1L)
- •\-Supine systolic blood pressure \< 85 mmHg
- •\-Significant orthostatic hypotension
- •\-standing blood pressure \< 80 mmHg or a blood pressure drop \> 20 mmHg when changing from a supine to a standing position
- •\-Uncontrolled hypertension
- •\-Uncontrolled cardiac arrhythmias
Outcomes
Primary Outcomes
Not specified
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