Heart Failure With Preserved Ejection Fraction (HFPEF), Hemodialysis, Sacubitril/Valsartan
Conditions
Brief summary
Heart failure is the most common cause of death of patients on chronic hemodialysis treatment, and to date there is no effective therapy for the treatment of this comorbidity in this group of patients. The most common form of heart failure in these groups of patients is heart failure with preserved ejection fraction (HFpEF). As a new therapy for heart failure, a new group of drugs called angiotensin receptor and neprilysin inhibitors (ARNI) has been imposed, whose representative is the drug sacubitril/valsartan. The therapy has been shown to be superior to any other therapy to date for the treatment of heart failure with reduced ejection fraction (HFrEF) and has been included in European and American guidelines for the treatment of patients with HFrEF. Since 2022, the drug has been approved in the USA for the treatment of patients with HFpEF, while in Europe it is still not approved for this indication. Currently, the drug is not approved for patients on chronic hemodialysis anywhere in the world, and its effect on this group of patients is unknown. There are very few studies examining the safety and efficacy of sacubitril/valsartan in chronic hemodialysis patients with HFpEF. Precisely because of this, the aim of this study is to determine the effectiveness of this drug in these groups of patients. I will conduct the research as a randomized controlled trial (single blind research) where the subjects will be patients on chronic hemodialysis treatment who have proven HFpEF. HFpEF is proven by the HFA-PEFF scale. The patients will be divided into two groups - the test group and the control group (30 patients in each group). The input variables will be patients on chronic hemodialysis treatment (whose hemodialysis treatment lasts at least one year); patients with heart failure with preserved ejection fraction; height; weight. Output variables will be heart ultrasound parameters and laboratory findings (NTproBNP, hs troponin, aldosterone, renin). The aim of the study is to determine the effect of sacubitril/valsartan on ultrasound parameters and on cardiovascular and other biomarkers in patients on chronic hemodialysis treatment with HFpEF.
Interventions
30 patients on chronic hemodialysis with proven heart failure with preserved ejection fraction will receive sacubitril/valsartan
Sponsors
University Clinical Hospital Mostar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients on chronic hemodialysis treatment (minimum 1 year); confirmed diagnosis of HFpEF; systolic arterial pressure \>100 mmHg. \-
Exclusion criteria
patients not on chronic hemodialysis treatment; patients with unconfirmed diagnosis of HFpEF; patients with systolic blood pressure \<100 mmHg; patients unwilling to participate in the study; \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left atrial volume index (LAVI) | 2 months | Change in left atrial volume index (LAVI), measured by transthoracic echocardiography using the biplane area-length method and indexed to body surface area (mL/m²). LAVI will be calculated according to current echocardiographic guidelines. The outcome is defined as the absolute change in LAVI from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular global longitudinal strain (LV GLS) | 2 months | Change in left ventricular global longitudinal strain (LV GLS), assessed by two-dimensional speckle-tracking echocardiography. LV GLS will be measured from standard apical views and expressed as a percentage (%). The outcome is defined as the absolute change in LV GLS from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group. |
| Change in E/e' ratio | 2 months | Change in left ventricular filling pressure estimated by the E/e' ratio, measured by transthoracic echocardiography. Early diastolic transmitral flow velocity (E wave) will be obtained using pulsed-wave Doppler at the mitral valve leaflet tips, and early diastolic mitral annular velocity (e') will be measured by tissue Doppler imaging at the septal mitral annulus. The outcome is defined as the absolute change in E/e' ratio from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group. |
| Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) | 2 months | Change in plasma concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP), measured using a standardized immunoassay and expressed in pg/mL. The outcome is defined as the absolute change in NT-proBNP levels from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group. |
Countries
Bosnia and Herzegovina
Contacts
CONTACTIvan Zeljko, M. D.
Outcome results
None listed