NCT04116034 (RED DESERT) is a NA clinical trial of alfapump DSR system in Heart Failure, sponsored by Sequana Medical N.V..

Who is sponsoring NCT04116034?

NCT04116034 is sponsored by Sequana Medical N.V..

What drugs are being tested in NCT04116034?

Interventions in NCT04116034: alfapump DSR system.

What condition does NCT04116034 study?

NCT04116034 studies Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome, Volume Overload, Sodium Excess, Sodium Disorder.

Is NCT04116034 still recruiting?

NCT04116034 is currently completed. Last updated 28 May 2021.

Last reviewed 2021-05-28 · How we verify

NCT04116034: RED DESERT

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

Alfapump Direct Sodium Removal (DSR) Feasibility Study

Completed NA Last updated 28 May 2021

What this trial tests

NA trial testing alfapump DSR system in Heart Failure in 8 participants. Completed in 15 April 2021.

Timeline

26 December 2019

Primary endpoint
15 April 2021

15 April 2021

Quick facts

Lead sponsor	Sequana Medical N.V.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	8
Start date	26 December 2019
Primary completion	15 April 2021
Estimated completion	15 April 2021
Sites	2 locations across Belgium, Georgia

Drugs / interventions tested

alfapump DSR system

Conditions studied

Heart Failure — all drugs for Heart Failure →
Congestive Heart Failure — all drugs for Congestive Heart Failure →
Cardiorenal Syndrome — all drugs for Cardiorenal Syndrome →
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 Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.

Publications & conference data

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

Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.
Fudim M, Abraham WT, von Bardeleben RS, Lindenfeld J, et al · · 2021 · cited 66× · PMID 34446165 · DOI 10.1016/j.jacc.2021.06.040
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 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
NCT04882358 — Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion · NA · unknown
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 NCT04116034 (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: 28 May 2021

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/NCT04116034.

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