Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

Launched by IRCCS OSPEDALE SAN RAFFAELE · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how quickly increasing heart failure medications after a special heart valve procedure can help patients with heart failure who have a reduced ability to pump blood. The goal is to see if this faster approach can lower a specific protein in the blood that indicates heart stress and improve overall health and quality of life for patients over six months. The study will compare this intensive treatment to standard care to find out which is more effective.

To be eligible for this trial, participants should be adults aged between 65 and 85 who have been hospitalized for serious valve diseases like aortic stenosis or mitral regurgitation and have heart failure. They must show specific signs of heart failure and have been on lower doses of their heart medications. If someone joins, they can expect close monitoring through various assessments during the study. It's important to note that certain health conditions or recent medical treatments may prevent someone from participating. This trial aims to find better ways to manage heart failure after valve interventions, which could lead to improved outcomes for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Hospital admission for severe symptomatic valve disease (aortic stenosis, mitral regurgitation, or tricuspid regurgitation) effectively treated with transcatheter valve intervention (TVI) during hospitalization.
• • Chronic heart failure with reduced ejection fraction (HFrEF)
• * At the time of randomization (1-2 days prior to discharge):
• • 1. NT-proBNP \> 900 pg/mL.
• • 2. Systolic blood pressure ≥ 100 mmHg.
• • 3. Heart rate ≥ 60 bpm.
• • 4. Serum potassium ≤ 5.0 mEq/L (mmol/L).
• • At the time of hospital admission treated with ≤ ½ of the of optimal dose of ACEi/ARB/ARNi, ≤ ½ of the of optimal dose of beta-blocker, and ≤ ½ of the of optimal dose of MRA, either with or without SGLT2ic.
• • Residency in the Lombardy region.
• • Written informed consent to participate in the study.
• Exclusion Criteria:
• • Age \< 18 or \> 85 years.
• • Clearly documented intolerance to ACEi/ARB/ARNI, or beta-blockers, or MRA, or SGLT2i.
• • Residual severe valve disease of the valve treated with TVI (i.e. severe aortic stenosis or severe paravalvular leak after TAVR, severe mitral stenosis or severe residual mitral regurgitation after mitral valve intervention, or severe tricuspid stenosis or severe residual tricuspid regurgitation after tricuspid valve intervention).
• • Presence at the time of randomization (1-2 days prior to discharge) of any severe valve disease.
• • Hemodynamically significant obstructive lesion of the left ventricular outflow tract.
• • Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right HF such as primary pulmonary hypertension or recurrent pulmonary embolism.
• • Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy device implantation within 3 months, or percutaneous transluminal coronary intervention, within 1 month prior to screening.
• • Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
• • History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.
• • Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
• • Active infection at any time during hospitalization requiring intravenous antibiotics.
• • Stroke or TIA within 3 months prior to screening.
• • Primary liver disease considered to be life threatening.
• • Renal disease or eGFR \< 30 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at screening or history of dialysis.
• • Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \<12 months.
• • Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening.
• • Discharge to a rehabilitation of long-term care facility.
• • Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures
• • Pregnant or nursing (lactating) women.