Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Recruiting Phase 1 Phase 2 Interventional Study
Congestive Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Iperboreal Pharma Srl · Industry
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About This Trial

Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥18 yrs * Left ventricular ejection fraction ≤60% * NYHA Classification of III-IV despite guidelines directed medical therapy * Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid calve regurgitation (≥ moderate) and by the dispropo…
Contacts

Arduino Arduini, MD

+41 79 7878312

a.arduini@corequest.ch

CONTACT