Glycocalyx restoration in chronic heart failure: a proof of concept, randomized, double-blind, placebo-controlled study
Phase 2
Recruiting
- Conditions
- Heart failure with reduced ejection fraction (HFrEF)10019280
- Registration Number
- NL-OMON51489
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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
- 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.
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> Bloodpressure<br /><br>Hemodynamic parameters<br /><br>Fluid status<br /><br>Monocyte subsets<br /><br>Monocyte surface proteins<br /><br>Quality of life<br /><br>Distance covered during six minute walking test<br /><br>Incidence of (serious) adverse events.</p><br>