Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
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).