Sulodexide for chronic heart failure

Phase 1

• Conditions: Chronic heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-002864-30-NL
• Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-23
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To determine the contribution of different potential working mechanisms of sulodexide in heart failure patients.<br>- To confirm the previously demonstrated safety of sulodexide in subjects with heart failure.<br>;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

Secondary Outcome Measures

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