An observational study in Heart Failure, sponsored by Centro Cardiologico Monzino. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Centro Cardiologico Monzino · Observational
Background: Sacubitril/valsartan, a novel therapy in the treatment of heart failure with reduced ejection fraction (HFrEF), has recently proved efficacy in improving exercise tolerance and cardiac performance. Cardiopulmonary exercise test (CPET) provides functional prognostic parameters for patient with HFrEF (i.e. peakVO2 and ventilation/CO2 production [VE/VCO2] slope) and it is a well-recognized, valuable, accurate tool for risk stratification.
Aim of the study and methods: The aim of the study is to prospectively enroll a cohort of 100 HFrEF outpatients eligible for sacubitril/valsartan and perform serial CPET, laboratory and echocardiographic assessments before and during the gradual titration of the treatment, in order to evaluate its effects on cardiopulmonary function and left ventricular remodeling. The procedures will be repeated along the follow-up at 1, 2 and 3 months after the enrollment (titration period) and at 6 months after the reach of the maximum tolerated dose.
Given the recent introduction of the drug into the clinical routine, the evaluation of the experience "on the field" is important to refine the clinical management of patients treated with sacubitril / valsartan. Furthermore, at the moment sacubitril / valsartan has proven effective in some small preliminary studies in improving the ejection fraction and some echocardiographic parameters of ventricular remodeling on top of the concomitant optimal medical therapy, although further data are needed in this regard.
In particular, the potential benefits on exercise capacity, respiratory function parameters and left ventricular remodeling in heart failure patients treated with sacubitril / valsartan has not been studied extensively at the moment. In this regard, the cardiopulmonary exercise test (CPET) allows to obtain prognostic functional parameters in patients with chronic heart failure such as peak V02 (peak V02) and the ventilation / production of C02 slope (VE / VC02 slope). CPET is a valid, recognized and accurate tool for risk stratification in heart failure patients.
Furthermore, few data are available on lung diffusion (DLCO) and on specific markers of the alveolar-capillary membrane, such as type B surfactant proteins (SPB) in patients treated with sacubtril / valsartan. Our team has already shown how these biomarkers and DLCO are influenced by drug treatments such as Levosimendan and Ace inhibitors.
The aim of the study is to evaluate the exercise capacity, spirometry, echocardiographic parameters of left ventricular sistolic and diastolic function, Nt-proBNP dosage and quality of life and the related dose-effect correlation in a multicenter cohort of 100 patients with stable heart failure (class functional NYHA II e lII) and reduced left ventricular ejection fraction in patients eligible for sacubitril / valsartan treatment.
A subgroup of patients will be also analyzed for data relating to the effect of sacubitril / valsartan on DLCO and blood levels of Surfactant Bindig protein (SPB).
Sacubitril / Valsartan will be prescribed according to guidelines, initially at the lowest dosage of 24/26 mg b.i.d. to verify its tolerability with the prospect of gradually increasing the dosage during subsequent follow-up visits. The re-evaluation of the treatment and the titration of the sacubitril / valsartan dose will take place every 4 weeks until the maximum tolerated dose is reached. The dose under study will be the maximum tolerated by the patient (however not higher than 97 mg / 103mg bd).
Cardiological examination with ECG, spirometry, CPET, the Kansas City Cardiomyopathy Questionnaire, blood count, creatinine, nitrogen, sodium, potassium, chlorine and NTproBNP will be performed at each visit (from Baseline to 6 months). The colordoppler echocardiogram will instead be performed only at the baseline and after 6 months.
A subset of patients will also be subjected to analysis of the blood levels of SPB and DLCO at baseline and 6 months after reaching the maximum tolerated dose.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 112 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HFrEF outpatients eligible for sacubitril/valsartan according to guidelines and perform serial CPET, laboratory and echocardiographic assessments before and during the gradual titration of the treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
outpatients with heart failure with reduced ejection fraction in treatment with sacubitril/valsartan according to guidelines
Drug: Sacubitril-Valsartan
outpatients who start treatment with sacubitril/valsartan according to guidelines will andergo cardiopulmonary exercise testing evaluation
VO2 evaluation after treatment
changes in peak VO2 at cardiopulmonary exercise test
Time frame: 1 month after start of treatment with sacubitril/valsartan
VO2 evaluation after treatment
changes in peak VO2 at cardiopulmonary exercise test
Time frame: 2 months after start of treatment with sacubitril/valsartan
VO2 evaluation after treatment
changes in peak VO2 at cardiopulmonary exercise test
Time frame: 3 months after start of treatment with sacubitril/valsartan
VO2 evaluation after treatment
changes in peak VO2 at cardiopulmonary exercise test
Time frame: 9 months after start of treatment with sacubitril/valsartan
lung function evaluation after treatment
changes in FVC, FEV1, PEF and FEV1%, by spirometry
Time frame: 1 month after start of treatment with sacubitril/valsartan
lung function evaluation after treatment
changes in FVC, FEV1, PEF and FEV1%, by spirometry
Time frame: 2 months after start of treatment with sacubitril/valsartan
lung function evaluation after treatment
changes in FVC, FEV1, PEF and FEV1%, by spirometry
Time frame: 3 months after start of treatment with sacubitril/valsartan
lung function evaluation after treatment
changes in FVC, FEV1, PEF and FEV1%, by spirometry
Time frame: 9 months after start of treatment with sacubitril/valsartan
DLCO
DLCO evaluation
Time frame: 1 month after start of treatment with sacubitril/valsartan
DLCO
DLCO evaluation
Time frame: 9 months after start of treatment with sacubitril/valsartan
Surfactant B-type protein after treatment
SPB quantification
Time frame: 1 month after start of treatment with sacubitril/valsartan
Surfactant B-type protein after treatment
SPB quantification
Time frame: 9 months after start of treatment with sacubitril/valsartan
left ventricular remodeling
ejection fraction
Time frame: 1 month after start of treatment with sacubitril/valsartan
left ventricular remodeling
ejection fraction
Time frame: 2 months after start of treatment with sacubitril/valsartan
left ventricular remodeling
ejection fraction
Time frame: 9 months after start of treatment with sacubitril/valsartan
left ventricular remodeling
End-diastolic and end-systolic left ventricular volumes
Time frame: 1 month after start of treatment with sacubitril/valsartan
left ventricular remodeling
End-diastolic and end-systolic left ventricular volumes
Time frame: 2 months after start of treatment with sacubitril/valsartan
left ventricular remodeling
End-diastolic and end-systolic left ventricular volumes
Time frame: 9 months after start of treatment with sacubitril/valsartan
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centro Cardiologico Monzino