NCT05284955 (SAINTS B) is a Phase 4 clinical trial of CardioMEMS HF System in Advanced Heart Failure, sponsored by Finn Gustafsson.

Who is sponsoring NCT05284955?

NCT05284955 is sponsored by Finn Gustafsson.

What drugs are being tested in NCT05284955?

Interventions in NCT05284955: CardioMEMS HF System, Standard heart failure medical therapy.

What condition does NCT05284955 study?

NCT05284955 studies Advanced Heart Failure, Heart Failure With Reduced Ejection Fraction.

Is NCT05284955 still recruiting?

NCT05284955 is currently status unknown. Last updated 20 March 2023.

Last reviewed 2023-03-20 · How we verify

NCT05284955: SAINTS B

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

Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)

Status unknown Phase 4 Last updated 20 March 2023

What this trial tests

Phase 4 trial testing CardioMEMS HF System in Advanced Heart Failure in 60 participants. Status unknown.

Timeline

2 March 2023

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Finn Gustafsson
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	2 March 2023
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across Denmark

Drugs / interventions tested

CardioMEMS HF System
Standard heart failure medical therapy — full drug profile →

Conditions studied

Advanced Heart Failure — all drugs for Advanced Heart Failure →
Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →

Sponsor

Finn Gustafsson — full company profile →

Who can join

Adults 19 to 74, any sex, with Advanced Heart Failure or Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Included patients will be randomized in a 1:1 ratio to pharmacological HF treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) or usual care consisting of pharmacological HF treatment. Patients randomized into the CardioMEMS arm will be implanted within 30 (Cardiomems group only) days from randomization. After randomization, patients in both the CardioMEMS and the control arm will be seen at the outpatient clinic at Rigshospitalet after one and 6 months. At the final clinical follow-up visit at 6 months, participants will perform a 6 minute walk test (6MWT), cardiopulmonary exercise test (CPET), fill out a quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire (KCCQ)) and blood samples will be drawn. Patients in the CardioMEMS arm will be managed according to previously published protocols for pulmonary artery pressure optimization (generally mean pulmonary pressure 10-25 mmHg) (Ref 1).

Publications & conference data

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

Remote pulmonary artery pressure-guided management of patients with heart failure: A clinical consensus statement of the Heart Failure Association (HFA) of the ESC.
Bayes-Genis A, Pagnesi M, Codina P, Abraham WT, et al · · 2025 · cited 10× · PMID 40288763 · DOI 10.1002/ejhf.3619
Invasive and Non-Invasive Remote Patient Monitoring Devices for Heart Failure: A Comparative Review of Technical Maturity and Clinical Readiness.
Luque I, Gadea M, Comas A, Becerra-Fajardo L, et al · · 2025 · cited 1× · PMID 41157505 · DOI 10.3390/s25206453

Verify or expand the search:

Other trials of CardioMEMS HF System

Trials testing the same drug.

NCT06306573 — CardioMEMS HF System Real-World Evidence Post-Approval Study · enrolling by invitation
NCT04078243 — Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmo · recruiting

Other recruiting trials for Advanced Heart Failure

Currently open trials in the same condition.

NCT07497308 — GDF-15 and Early Outcomes After LVAD Implantation · recruiting

Other Finn Gustafsson trials

Trials by the same sponsor.

NCT06671990 — The CardioMEMS Vericiguat Heart Failure Trial · Phase 4 · not yet recruiting
NCT03576677 — Effect of Levosimendan or Placebo on Exercise in Advanced Chronic Heart Failure · Phase 4 · unknown
NCT03844516 — Pacing in Left Ventricular Assist Device Recipients · NA · unknown

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 NCT05284955 (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 Finn Gustafsson
Last refreshed: 20 March 2023

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/NCT05284955.

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