To assess the efficacy of treatment with Endocalyx for chronic heart failure.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percent change of NT-proBNP from baseline to week 8
Secondary outcome
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.
Background summary
Chronic heart failure is characterized by sodium and water overload
despite lifestyle advices and drug therapy. The endothelial surface layer (ESL)
is able to neutralize the negative effects of sodium excess such as water
retention and high blood pressure. The ESL is damaged in heart failure
patients. Restoration of the ESL with Endocalyx, an oral supplement consisting
of ESL constituents, is therefore hypothesized to lower sodium and water excess
in heart failure patients.
Study objective
To assess the efficacy of treatment with Endocalyx for chronic heart
failure.
Study design
A proof-of-principle randomized, placebo-controlled, double blind trial
Intervention
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.
Study burden and risks
Subjects need to take the study supplements daily for eight weeks. The study
supplements are already available online in the United States and to date no
major side effects have been reported.
There will be a total of 5 study visits. A 24-hour blood pressure measurement
will be performed, and 24-hour urine will be collected, three times.
Blood will be sampled, four times, with a total volume of 100mL. All subjects
will be asked to fill in a questionnaire, 3 times. Several non-invasive
measurements, including office blood pressure and micorcirculation
measurements, will be performed.
A total of 16 subjects will be approached for a total of 4 (invasive) skin
biopsies. This will only be performed if the subject has given consent for the
biopsies.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Chronic heart failure with reduced ejection fraction (HFrEF)
- Elevated NT-proBNP and signs of congestion (e.g. use of diuretics, peripheral
edema)
- Stable diuretic and antihypertensive treatment
Exclusion criteria
Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2
- Systolic (<105 mmHg) or diastolic hypotension (<60 mmHg)
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81588.018.22 |