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NCT04241718
A Feasibility Study on Ultrafiltration and Blood Volume Measurements
NA trial testing Aquadex FlexFlow System and BVA-100 in Acute Decompensated Heart Failure in 6 participants. Terminated before completion.
27 December 2022
Quick facts
| Lead sponsor | Nuwellis, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 6 |
| Start date | 19 December 2019 |
| Primary completion | 27 December 2022 |
| Estimated completion | 27 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aquadex FlexFlow System and BVA-100
Conditions studied
- Acute Decompensated Heart Failure — all drugs for Acute Decompensated Heart Failure →
- Fluid Overload — all drugs for Fluid Overload →
Sponsor
Nuwellis, Inc. — full company profile →
Who can join
18 and older, any sex, with Acute Decompensated Heart Failure or Fluid Overload. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04241718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06556810 — IC14 for Treatment of Acute Decompensated Heart Failure · Phase 1, PHASE2 · active not recruiting
- NCT06714409 — Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure · NA · recruiting
Other Nuwellis, Inc. trials
Trials by the same sponsor.
- NCT05318105 — Ultrafiltration Versus IV Diuretics in Worsening Heart Failure · NA · recruiting
- NCT04644731 — Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds) · terminated
- NCT01872949 — C-Pulse® System European Multicenter Study · completed
- NCT01740596 — C-Pulse® System: A Heart Assist Device Clinical Study · NA · terminated
- NCT01176370 — C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04241718 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nuwellis, Inc.
- Last refreshed: 14 November 2024
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/NCT04241718.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing