Status:
COMPLETED
The ENVI Study: Effect of Entresto on Left Ventricular Remodelling on Cardiac MRI
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
Brief Summary
A prospective, single centre, observational cohort study at University Hospital Southampton NHS Foundation Trust of 50 consecutive patients with Heart Failure with reduced Ejection Fraction and Ejecti...
Detailed Description
The landmark trial PARADIGM-HF (2014) showed that a new drug sacubitril/valsartan (Entresto) was superior to a well-established drug (ACE-Inhibitors) for patients with severe heart failure. Entresto r...
Eligibility Criteria
Inclusion
- ≥18 years
- HFrEF EF ≤35% despite optimisation of ACE-Inhibitor, Beta Blocker \& Mineralocorticoid Receptor Antagonist and referred for Entresto initiation
- Symptomatic NYHA II-III
- Able and willing to provide informed consent
- Able to undergo Cardiac Magnetic Resonance Imaging (CMR) scan
Exclusion
- Pre-existing cardiac device (i.e. pacemaker/defibrillator)
- Symptomatic hypotension (BP \<95mmHg) - \[PARADIGM exclusion\]
- Severe renal failure (GFR \<30)
- Hyperkalaemia (K \>5.4mmol/L)
- History of angioedema
- Diagnosis of amyloidosis, sarcoidosis or HCM
- Myocardial infarction or revascularisation within the last 40 days
- Valve disease expected to require surgery
- Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
- Pregnancy
Key Trial Info
Start Date :
June 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05348226
Start Date
June 9 2021
End Date
March 23 2023
Last Update
April 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD