Heart failure with (mildly) reduced ejection fraction (HF(m)rEF)
Conditions
Interventions
Endocalyx (total of 4 capsules per day
twice per day 2 capsules or
once daily 4 capsules ) for 8 weeks versus placebo once daily for 8 weeks.
There will be a follow up studyvisit in week 12.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Chronic heart failure with (mildly) reduced ejection fraction (HF(m)rEF) - Elevated NT-proBNP and signs of congestion (e.g. use of diuretics, peripheral edema) - Stable diuretic and antihypertensive treatment
Exclusion criteria
Exclusion criteria: Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2 - Severe symptoms of (orthostatic) hypotension. - A cardiovascular event in the last 3 months. - Hospitalization for heart failure in the past 3 weeks or major surgery in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of NT-proBNP from baseline to week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Bloodpressure Hemodynamic parameters Fluid status Monocyte subsets Monocyte surface proteins Quality of life Distance covered during six minute walking test Incidence of (serious) adverse events. | — |
Countries
Netherlands
Contacts
Public ContactC.L. Zwager
Amsterdam UMC
Outcome results
None listed