Sulodexide for chronic heart failure

Sulodexide for chronic heart failure: a proof of concept, randomized, placebo-controlled study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002864-30-NL

Enrollment

Registered

2020-06-23

Start date

2020-07-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Trade Name: VESSEL DUE F Pharmaceutical Form: Capsule INN or Proposed INN: SULODEXIDE CAS Number: 57821-29-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Main Objective: To assess whether sulodexide treatment reduces sodium and water excess in patients with chronic heart failure.;Secondary Objective: - To evaluate whether sulodexide treatment will improve patient-reported outcomes such as fluid overload symptoms and quality of life. - To determine the contribution of different potential working mechanisms of sulodexide in heart failure patients. - To confirm the previously demonstrated safety of sulodexide in subjects with heart failure. ;Primary end point(s): Percentage change in N-terminal pro-B-type natriuretic peptide (NT-proBNP);Timepoint(s) of evaluation of this end point: Baseline versus 8 weeks	—

Measure

Time frame

Main Objective: To assess whether sulodexide treatment reduces sodium and water excess in patients with chronic heart failure.;Secondary Objective: - To evaluate whether sulodexide treatment will improve patient-reported outcomes such as fluid overload symptoms and quality of life. - To determine the contribution of different potential working mechanisms of sulodexide in heart failure patients. - To confirm the previously demonstrated safety of sulodexide in subjects with heart failure. ;Primary end point(s): Percentage change in N-terminal pro-B-type natriuretic peptide (NT-proBNP);Timepoint(s) of evaluation of this end point: Baseline versus 8 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Blood pressure - Hemodynamic parameters - Fluid status - Change in adrenomedullin (ADM) - Monocyte subsets - Monocyte surface proteins - Dyspnea symptoms, physical limitations and quality of life - Hospitalizations due to heart failure - Distance covered during six minute walking test - WHO grade II-IV bleeding events - Incidence of (serious) adverse events;Timepoint(s) of evaluation of this end point: Baseline versus 8 weeks	—

Measure

Time frame

Secondary end point(s): - Blood pressure - Hemodynamic parameters - Fluid status - Change in adrenomedullin (ADM) - Monocyte subsets - Monocyte surface proteins - Dyspnea symptoms, physical limitations and quality of life - Hospitalizations due to heart failure - Distance covered during six minute walking test - WHO grade II-IV bleeding events - Incidence of (serious) adverse events;Timepoint(s) of evaluation of this end point: Baseline versus 8 weeks

—

Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

Amsterdam UMC, location AMC

r.h.oldeengberink@amsterdamumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026