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: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finn Gustafsson
• Collaborators: Abbott; Novo Nordisk A/S

Criteria

Inclusion Criteria:

1. Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), but not referred for HTx or LVAD due to contraindications or patient preference

2. NYHA Functional class III

3. Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements

Exclusion Criteria:

1. Systolic blood pressure < 90 mmHg

2. Chest circumference of > 165 cm if BMI is ≥35 kg/m2

3. Intolerance to all neurohormonal antagonists (i.e., intolerance to Angiotensin Converting Enzyme inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Angiotensin receptor II blocker - neprilysin inhibitor (ARNi), Mineralocorticoid Receptor Antagonists (MRA), hydralazine/isosorbide dinitrate, and betablockers)

4. Fluid overload with a maximum (or dose equivalent) diuretic intervention

5. Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation

6. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS pulmonary artery sensor

7. Implanted with mechanical right heart valve(s)

8. Pregnant or planning to become pregnant in the next 12 months

9. An active, ongoing infection

10. History of current or recurrent (≥2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thromboses