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

NCT05284955 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-20

No results posted yet for this study

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).

Conditions

  • Advanced Heart Failure
  • Heart Failure With Reduced Ejection Fraction

Interventions

DEVICE

CardioMEMS HF System

The CardioMEMS HF System is a wireless pulmonary artery pressure monitor. We will use measurements from the device to guide medical heart failure therapy.

DRUG

Standard heart failure medical therapy

Standard heart failure medical therapy as recommended by guidelines.

Sponsors & Collaborators

Principal Investigators

  • Finn Gustafsson, MD, professor, PhD, DMSci · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-02
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284955 on ClinicalTrials.gov