An interventional study of Rapid Uptitration of Guideline-Directed Medical Therapy and Elecsys® NT-proBNP - Roche Diagnostics in Heart Failure, Valvulopathy and Aortic Stenosis, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by IRCCS Ospedale San Raffaele · Not applicable, Interventional, and Treatment
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.
Heart valve disease, with a current prevalence of 2.5% that rises with age, has been described as "the next cardiac epidemic", and is projected to double by 2040 and triple by 2060, paralleling population aging.
The period during and immediately after hospitalization for transcatheter valve intervention (TVI) in HFrEF patients (LVEF ≤ 40%) represents a "vulnerable phase" characterized by a high risk of death and re-hospitalization for acute HF. A study from the TVI registry demonstrated that, among 12.182 patients treated with TAVR in the United States, the rate of HF readmission at 1 year was 14.3% and the 1-year overall mortality was 23.7%.
Moreover, the CHOICE-MI registry demonstrated that the primary combined endpoint of all-cause mortality or HF hospitalization at 1 year occurred in 39.2% of the Transcatheter mitral valve implantation (TMVI) patients, and in 28% in those TMVI-ineligible who undergoing bailout-TEER.
Recently, the STRONG-HF trial demonstrated that rapid, intensive up-titration of guideline-directed therapy, coupled with close post-discharge follow-up, significantly enhances life quality and reduces 180-day mortality and heart failure readmission rates versus usual care.
Previous studies have additionally shown that a decrease in NT-proBNP levels during hospitalization for acute HF is associated with improved survival and reduced readmission rates. Patients whose NT-proBNP levels decrease by at least 30% tend to have a better prognosis compared to those with no significant change or an increase in levels. This suggests that a meaningful decrease in NT-proBNP levels can indicate successful response to HF treatment.
Consequently, guiding HF therapy based on NT-proBNP levels can potentially improve clinical outcomes. For instance, adjusting medications to achieve a target NT-proBNP level may result in better control of HF symptoms and a lower risk of hospital readmission and mortality. This approach emphasizes the role of NT-proBNP as not just a diagnostic and prognostic tool but also as a therapeutic target in HF management. Overall, the use of NT-proBNP monitoring to guide medical therapy in HF patients supports a more personalized treatment strategy, potentially leading to rapid and effective decongestion, optimized therapy, and improved patient outcomes.
Hence, the primary objective of this study is to assess the impact of rapid up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with HFrEF undergoing transcatheter valvular intervention, supplemented by close follow-up visits and NT-proBNP measurements, using a hierarchical composite endpoint, which prioritize (1) all-cause mortality, (2) number of hospitalizations for heart failure, and (3) improvement in NT-proBNP, defined as a decrease of at least 30% from the baseline value.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 160 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →IRCCS Ospedale San Raffaele is the lead sponsor of 34 studies on the registry; 27 are open to participants now.
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At the time of randomization (1-2 days prior to discharge):
Exclusion Criteria:
Participants receive standard follow-up care with Guideline-Directed Medical Therapy (GDMT) adjustments as per the physician's usual practice.
Patients will undergo rapid up-titration of GDMT. Their progress will be closely monitored using Point-of-Care (PoC) technology from Roche Diagnostics for NT-proBNP measurements.
Other: Rapid Uptitration of Guideline-Directed Medical Therapy · Diagnostic Test: Elecsys® NT-proBNP - Roche Diagnostics
Patients will undergo rapid up-titration of GDMT. Their progress will be closely monitored using hospital-based blood tests (Roche Elecsys central laboratory platform).
Other: Rapid Up-Titration GDMT Group with Hospital Monitoring
Rapid up-titration of GDMT guided by protocol-specific guideline.
An assay provided by Roche (Elecsys® NT-proBNP - Roche Diagnostics) will be used to assess NT-proBNP levels in the Rapid Up-Titration GDMT Group with Point-of-Care (PoC) Monitoring, with the purpose of evaluating any differences in marker dosage between the indicated method and the monitoring by the hospital laboratory analysis.
Also known as: Point-of-Care (PoC) Monitoring
Rapid Up-Titration GDMT Group guided by protocol-specific guideline and hospital monitoring.
Composite Hierarchical Outcome for Mortality, Heart Failure Hospitalization, and NT-proBNP Response
Hierarchical composite endpoint composed of (1) all-cause death, (2) number of HF hospitalization, (3) improvement of NT-proBNP (with an improvement defined as a decrease of at least 30% from baseline).
Time frame: From enrollment to the end of treatment (up to 6 months).
Incidence of cardiovascular death
The incidence of death attributable to cardiovascular causes, including sudden cardiac death, myocardial infarction, or worsening heart failure.
Time frame: From enrollment to the end of treatment (up to 6 months).
Rate of Heart Failure Readmission
The rate of hospital readmission due to worsening heart failure symptoms, requiring inpatient care following discharge from the initial intervention.
Time frame: From enrollment to the end of treatment (up to 6 months).
Composite endpoint of Heart Failure Readmission or All-Cause Death
A composite endpoint measuring the incidence of either heart failure-related hospital readmission or death from any cause.
Time frame: From enrollment to the end of treatment (up to 6 months).
Change in Quality of Life according to the European Heart Failure Self-care Behaviour Scale
Assessment of patient-reported quality of life changes using the European Heart Failure Self-care Behaviour Scale (EHFScBS), a 9-items scale where higher score means worse self care (possible range 9 - 45).
Time frame: From enrollment to the end of treatment (up to 6 months).
Change in Quality of Life according to the Kansas City Cardiomyopathy Questionnaire
Assessment of patient-reported quality of life changes using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated health status measure for patients with heart failure. It contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status.
Time frame: From enrollment to the end of treatment (up to 6 months).
Changes in NT-proBNP Levels
Evaluation of the reduction in NT-proBNP levels from baseline to study completion as a biomarker of heart failure status improvement.
Time frame: From enrollment to the end of treatment (up to 6 months).
Plan to share: Undecided
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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IRCCS Ospedale San Raffaele