Status:
UNKNOWN
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
19-74 years
Brief Summary
The purpose of the Screening for Advanced heart failure IN stable ouTpatientS (SAINTS) study is to determine the prevalence of advanced heart failure (HF) in symptomatic patients with HF and reduced l...
Detailed Description
Number of patients and sample size More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the prim...
Eligibility Criteria
Inclusion
- History of Chronic heart failure \> 3 months
- Stable (no hospitalization last 3 months) NYHA functional class II-III
- HFrEF patients (Left ventricular ejection fraction (LVEF) ≤ 30%)
- On or attempted betablocker and Renin-Angiotensin System (RAS) inhibitor treatment
- Informed consent
Exclusion
- Body Mass Index (BMI) \> 40 kg/m2
- Chronic renal replacement therapy or estimated Glomerular Filtration Rate (eGFR) \< 15 ml/min/1.73m2
- Cardiac Resynchronization Therapy (CRT) implantation \< 3 months ago or planned CRT
- Severe primary valvular disease
- On waiting list for heart transplantation or referred for evaluation
- Cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
Key Trial Info
Start Date :
October 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05299879
Start Date
October 24 2022
End Date
December 1 2025
Last Update
November 1 2022
Active Locations (6)
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1
Bispebjerg-Frederiksberg Hospital
Copenhagen, Denmark, 2400
2
Amager/Hvidovre Hospital
Copenhagen, Denmark, 2650
3
Herlev and Gentofte Hospital
Copenhagen, Denmark, 2730
4
Glostrup Hospital
Glostrup Municipality, Denmark, 2600