Therapeutic outcomes of modulation of cardiometabolic peptides by Angiotensin Receptor-Neprilysin Inhibitor in patients of Heart Failure- A prospective observational study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Change in the serum levels of endothelin-1, neuropeptide Y, and bradykinins
Study Overview
Brief Summary
A novel class of angiotensin receptor-neprilysin inhibitor (ARNI) has been approved as a potential therapeutic avenue in patients of heart failure with reduced ejection fraction (HFrEF). While the inhibition of neprilysin and resulting elevation of natriuretic peptides is believed to exert cardioprotective effects, elevated levels of other neprilysin substrates such as endothelin-1, bradykinin, and neuropeptide Y is expected to cause deleterious effects such as cardiac fibrosis, pulmonary hypertension, impaired glucose tolerance and angioedema. The objectives of the present study are:• **Primary:**To assess the association between change in endothelin-1 levels and cardio-metabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy
• Secondary:
• To analyse association between change in neuropeptide Y (NPY) levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitrilcompared to standard care of therapy.
• To measure association between change in bradykinin levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy
. To assess adverse events in patients of HFrEF on valsartan-sacubitril and standard care of therapy
*To specify, cardiometabolic outcomes include 2-D echo markers such as left ventricular ejection fraction (LVEF), biochemical markers such as brain natriuretic peptide (BNP)and NT-pro BNP levels and metabolic parameters such as blood glucose and body weight
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients of 18 years of age and above and individuals of both genders diagnosed with heart failure (NYHA class II-IV) with ejection fraction less than 40 % irrespective of the etiology of heart failure and who give consent for participation in the study, shall be the study participants.
Exclusion Criteria
- •Patients of heart failure with a recent history of serious cardiovascular event such as myocardial infarction, stroke, or other thromboembolic event in last one month
- •Patients of heart failure with sepsis
- •Patients of heart failure with EF ≥ 40%
- •Patients who refuse to participate.
Outcomes
Primary Outcomes
Change in the serum levels of endothelin-1, neuropeptide Y, and bradykinins
Time Frame: at baseline, 4 weeks, 24 weeks
Secondary Outcomes
- • Improvement in 2-D Echo markers like(Left ventricle ejection fraction (LVEF), left ventricle end diastolic volume index (LVEDVI), left ventricle end systolic volume index (LVESVI), at 1-month, 6 month and 12 month compared to baseline.)
Investigators
Upinder Kaur
IMS-BHU