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

Phase 2

• Conditions: heart failure; 10019280

• Registration Number: NL-OMON49874
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• 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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percent change of NT-proBNP from baseline to week 8.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Blood pressure<br /><br>- Hemodynamic parameters<br /><br>- Fluid status<br /><br>- Monocyte subsets<br /><br>- Monocyte surface proteins<br /><br>- Dyspnea symptoms, physical limitations and quality of life<br /><br>- Distance covered during six minute walking test<br /><br>- WHO grade II-IV bleeding events<br /><br>- Incidence of (serious) adverse events</p><br>