Screening for advanced heart failure in stable outpatients
Screening for Advanced Heart Failure IN Stable ouTpatientS (The SAINTS Study) - Early Identification of Advanced Heart Failure
This study is trying to find out how many patients with heart failure have advanced heart failure by screening them in clinics and looking at their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 19 Years to 74 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 6 sites (Copenhagen and 5 other locations) |
| Trial ID | NCT05299879 on ClinicalTrials.gov |
What this trial studies
The SAINTS study aims to determine the prevalence of advanced heart failure in symptomatic patients with heart failure and reduced left ventricular ejection fraction. It will involve screening patients in Danish heart failure clinics using echocardiography and other assessments. The study will analyze the proportion of patients who meet the criteria for advanced heart failure and track subsequent management options such as heart transplantation and LVAD implantation. Statistical analyses will be performed to compare various health metrics between patients with and without advanced heart failure.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic heart failure for more than 3 months, in stable condition, classified as NYHA functional class II-III, and with reduced ejection fraction.
Not a fit: Patients with severe comorbidities, such as those on chronic renal replacement therapy or with a life expectancy of less than one year, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and treatment of patients with advanced heart failure, improving their outcomes.
How similar studies have performed: Other studies have shown success in identifying advanced heart failure using similar screening methods, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. History of Chronic heart failure \> 3 months 2. Stable (no hospitalization last 3 months) NYHA functional class II-III 3. HFrEF patients (Left ventricular ejection fraction (LVEF) ≤ 30%) 4. On or attempted betablocker and Renin-Angiotensin System (RAS) inhibitor treatment 5. Informed consent Exclusion Criteria: 1. Body Mass Index (BMI) \> 40 kg/m2 2. Chronic renal replacement therapy or estimated Glomerular Filtration Rate (eGFR) \< 15 ml/min/1.73m2 3. Cardiac Resynchronization Therapy (CRT) implantation \< 3 months ago or planned CRT 4. Severe primary valvular disease 5. On waiting list for heart transplantation or referred for evaluation 6. Cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
Where this trial is running
Copenhagen and 5 other locations
- Bispebjerg-Frederiksberg Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Amager/Hvidovre Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Herlev and Gentofte Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Glostrup Hospital — Glostrup, Denmark (Recruiting)
- Nordsjællands Hospital Hillerød — Hillerød, Denmark (Not_yet_recruiting)
- Zeeland University Hospital Roskilde — Roskilde, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Finn Gustafsson, MD, PhD, DMSci — Rigshospitalet, Denmark
- Study coordinator: Finn Gustafsson, MD, PhD, DMSci
- Email: finng@dadlnet.dk
- Phone: +45 35459743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.