Heart Failure MedDRA version: 14.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Vaprisol
Product Name: Vaprisol
Pharmaceutical Form: Infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Sponsors
Copenhagen University Hospital, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age > 18 years -LVEF =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 20 mmHg when changing from a supine to a standing position -Uncontrolled hypertension -Uncontrolled cardiac arrhythmias -Untreated serious hypothyroidism -Adrenal insufficiency -Poor echocardiographic window -Not able to perform exercise testing -Permanent atrial fibrillation or atrial fluttering -Planned coronary by-pass surgery -Moderate hepatic impairment (ALAT/ASAT > 3 UNL) -Presence of other diseases affecting treatment with conivaptan or the evaluation of safety -Severely decreased kidney function (eGFR 5.5 mmol/L -Conivaptan intolerability -Corn allergy -Treatment with potent CYP3A-inhibitors (ketoconazole, otrakonazole, clarithromycin, ritonavir, indinavir) -Treatment with arginine vasopressin, oxytocin, desmopressin and other medications for the treatment of hyponatremia (lithium salts, urea and demeocycline) -Warfarin treatment -Presence of infection or active bleeding -Need of inotropic circulatory support within the last 30 days -Pregnant women or fertile women not taking safe contraception -Women who are breastfeeding -Hemodynamically significant heart valve disease estimated by echocardiography -The ability to understand written and oral Danish -Contraindication to insertion of Swan-Ganz catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test if infusion of the V1A/V2-receptor blocker conivaptan improves hemodynamics and physical capacity in HF patients on optimal HF medical therapy and to improve understanding of the role of vasopressin in HF.;Secondary Objective: Not applicable;Primary end point(s): -PCWP at the submaximal exercise intensity of 50 % of the maximal exercise capacity ;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Cardiac index (CI) during submaximal exercise before and during conivaptan-infusion -Pulmonary and peripheral vascular resistance during exercise -Left ventricular end diastolic diameter during exercise -The Doppler-index of the left ventricular filling (E/e’) during exercise -The change in BNP, MR-ANP and copeptin from rest to submaximal exercise ;Timepoint(s) of evaluation of this end point: 1 day | — |
Countries
Denmark
Contacts
Public ContactFinn Gustafsson
Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed