Screening for advanced heart failure in stable outpatients
Efficacy of Pulmonary Pressure Guided Therapy in Stable Outpatients With Advanced Heart Failure - A Randomized Controlled Clinical Trial
This study is testing if a new heart monitoring system can help people with advanced heart failure feel better compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 74 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05284955 on ClinicalTrials.gov |
What this trial studies
The SAINTS B study is a randomized controlled trial that aims to evaluate the effectiveness of the CardioMEMS HF system in patients with advanced heart failure who are not candidates for heart transplantation or left ventricular assist devices. Participants will be randomized to receive either pharmacological treatment guided by the CardioMEMS system or standard care. The study will monitor patients over a six-month period, assessing their functional capacity and quality of life through various tests and questionnaires. Data will be meticulously recorded and analyzed to ensure accuracy and reliability.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced heart failure who are not eligible for heart transplantation or left ventricular assist devices and are willing to comply with monitoring requirements.
Not a fit: Patients with severe hypotension, fluid overload, or contraindications to the required medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of advanced heart failure, enhancing patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown promise with similar remote monitoring approaches in heart failure management, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 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
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Finn Gustafsson, MD, professor, PhD, DMSci — Rigshospitalet, Denmark
- Study coordinator: Finn Gustafsson, MD, professor, PhD, DMSci
- Email: finng@dadlnet.dk
- Phone: +45 3545 9743
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.