Who is sponsoring NCT04882358?

NCT04882358 is sponsored by Sequana Medical N.V..

What drugs are being tested in NCT04882358?

Interventions in NCT04882358: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM, SGLT2 inhibitor.

What condition does NCT04882358 study?

NCT04882358 studies Heart Failure, Volume Overload.

Is NCT04882358 still recruiting?

NCT04882358 is currently status unknown. Last updated 9 November 2022.

Last reviewed 2022-11-09 · How we verify

NCT04882358: SAHARA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion

Status unknown NA Last updated 9 November 2022

What this trial tests

NA trial testing ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM in Heart Failure in 24 participants. Status unknown.

Timeline

27 May 2021

Primary endpoint
31 August 2022

31 December 2024

Quick facts

Lead sponsor	Sequana Medical N.V.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	24
Start date	27 May 2021
Primary completion	31 August 2022
Estimated completion	31 December 2024
Sites	2 locations across Georgia

Drugs / interventions tested

ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM
SGLT2 inhibitor — full drug profile →

Conditions studied

Heart Failure — all drugs for Heart Failure →
Volume Overload — all drugs for Volume Overload →

Sponsor

Sequana Medical N.V. — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Volume Overload. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics. Up to 24 subjects will be enrolled in up to 3 centres in Republic of Georgia, and randomized into 2 parallel treatment arms. Once implanted with the alfapump DSR system they will undergo DSR therapy in 2 phases: intensive treatment phase followed by maintenance treatment phase.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Edema formation in congestive heart failure and the underlying mechanisms.
Abassi Z, Khoury EE, Karram T, Aronson D. · · 2022 · cited 48× · PMID 36237903 · DOI 10.3389/fcvm.2022.933215
Serial direct sodium removal in patients with heart failure and diuretic resistance.
Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, et al · · 2024 · cited 8× · PMID 38556717 · DOI 10.1002/ejhf.3196
Device-based therapy for decompensated heart failure: An updated review of devices in development based on the DRI<sub>2</sub>P<sub>2</sub>S classification.
de Oliveira Cardoso C, Elgalad A, Li K, Perin EC. · · 2022 · cited 6× · PMID 36211544 · DOI 10.3389/fcvm.2022.962839
Device-based therapies in cardio-renal syndrome: a pathophysiology-driven approach to a complex bidirectional disease
Echefu G, Sullivan R, Stowe I, Ukwuani P, et al ·
Advances and controversies in acute decompensated heart failure treatment: beta-blocker roles, emerging devices, and future directions.
Milhem F, Almur O, Hajjeh O, Bdair M, et al · · 2025 · PMID 40901193 · DOI 10.1097/ms9.0000000000003592

Verify or expand the search:

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting

Other Sequana Medical N.V. trials

Trials by the same sponsor.

NCT05965934 — Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0 · Phase 1, PHASE2 · unknown
NCT04116034 — Alfapump Direct Sodium Removal (DSR) Feasibility Study · NA · completed
NCT03973866 — Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study) · NA · unknown
NCT04326946 — International Alfapump Cohort Study · active not recruiting
NCT03032211 — Optimal Balance Alfapump® System Feasibility Study · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04882358 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sequana Medical N.V.
Last refreshed: 9 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04882358.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing