To assess the efficacy of treatment with sulodexide 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
- Blood pressure
- Hemodynamic parameters
- Fluid status
- Monocyte subsets
- Monocyte surface proteins
- Dyspnea symptoms, physical limitations and quality of life
- Distance covered during six minute walking test
- WHO grade II-IV bleeding events
- Incidence of (serious) adverse events
Background summary
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 subjects with heart failure.
Restoration of the ESL with sulodexide, an oral drug consisting of ESL
constituent, may therefore lower sodium and water excess in heart failure
patients.
Study objective
To assess the efficacy of treatment with sulodexide for chronic heart failure.
Study design
Proof-of-principle randomized, placebo-controlled trial.
Intervention
Sulodexide 100 mg once daily for 8 weeks or placebo.
Study burden and risks
Subjects need to take study medication every day for 8 weeks. A 24-hour blood
pressure measurement will be performed 3 times and 24-hour urine will be
collected 3 times. For safety reasons , blood will be sampled 4 times with a
total volume of 36 mL. All subjects will be asked to fill in questionnaires 3
times. We will perform several non-invasive measurements such as office blood
pressure measurements, microcirculation and hemodynamic Nexfin measurements. 10
patients will be approached for two optional skin biopsies at baseline and
after 8 weeks.
Treatment with sulodexide 100 mg has proven to be a safe treatment in >7,000
subjects with a follow-up duration up to 1 year. The incidence of adverse
events was comparable to placebo. More than half of these patients had
important cardiovascular co-morbidities and were within 2 weeks after acute
myocardial infarction.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
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
- Hypotension (systolic < 105 mmHg or diastolic < 60 mmHg)
- Anticoagulant therapy or double antiplatelet therapy
- Recent cardiovascular event or hospital admission for heart failure
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-002864-30-NL |
| CCMO | NL73019.018.20 |