Status:
UNKNOWN
Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)
Lead Sponsor:
Finn Gustafsson
Collaborating Sponsors:
Novo Nordisk A/S
Abbott
Conditions:
Advanced Heart Failure
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
19-74 years
Phase:
PHASE4
Brief 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 assis...
Detailed Description
Data recording: Data will be recorded in an online database using an electronic case report form. The investigators will use limits for accepted input, when applicable, on variables to minimize error...
Eligibility Criteria
Inclusion
- Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), although with a lower NT-proBNP cut-off level at ≥ 1000 pg/ml, but not referred for HTx or LVAD due to contraindications or patient preference
- NYHA Functional class III
- Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements
Exclusion
- Systolic blood pressure \< 90 mmHg
- Chest circumference of \> 165 cm if BMI is ≥35 kg/m2
- 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)
- Fluid overload with a maximum (or dose equivalent) diuretic intervention
- Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation
- Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS pulmonary artery sensor
- Implanted with mechanical right heart valve(s)
- Pregnant or planning to become pregnant in the next 12 months
- An active, ongoing infection
- History of current or recurrent (≥2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thromboses
Key Trial Info
Start Date :
March 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05284955
Start Date
March 2 2023
End Date
December 31 2025
Last Update
March 20 2023
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100