The ENVI Study: Effect of Entresto on Left Ventricular Remodelling on Cardiac MRI

NCT05348226 | Completed

• 1 other identifier: CAR0589
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 Ejection Fraction ≤35% who are eligible for sacubitril/valsartan (Entresto) initiation as per European Society of Cardiology guidelines. Participants will have baseline and repeat cardiac magnetic resonance imaging (CMR) scans after 4-6 months of Entresto therapy. The CMR scans will be compared. Clinical outcomes at 6 months including combined outcome of death and/or heart failure hospitalisation, KCCQ-12 questionnaire, 6-minute walk test, routine blood tests and NTproBNP will also be described. This study will be the first to examine the effects of sacubitril/valsartan (Entresto) therapy on left ventricular reverse remodelling in patients with symptomatic HFrEF as demonstrated by Cardiac Magnetic Resonance Imaging.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging

  Left ventricular Volume quantified in (ml)

  6 months

• Indexed Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging

  Weight and Height will be combined to calculate Body Surface Area (m2). Left Ventricular Volume in (ml) will be divided by Body Surface Area to give indexed value (ml/m2)

  6 months

• Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging

  Ejection Fraction quoted in (%)

  6 months

Secondary Outcomes (2)

• Cardiac Fibrosis quantification as measured by T1 mapping on Cardiac Magnetic Resonance Imaging

  6 months

• Strain Analysis as measured by feature tracking on Cardiac Magnetic Resonance Imaging

  6 months

Other Outcomes (4)

• Combined outcome of death and/or heart failure hospitalisation

  6 months

• Quality of Life assessment: KCCQ-12 questionnaire

  6 months

• Quality of Life assessment: 6 Minute Walk Test

  6 months

Interventions

Additional Cardiac Magnetic Resonance Scan DIAGNOSTIC_TEST

Standard of care medical treatment with sacubitril/valsartan (Entresto). Additional Cardiac Magnetic Resonance Imaging (CMR) Scan after 4-6 months of treatment.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic severe Heart Failure with reduced Ejection Fraction.

You may qualify if:

• ≥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

You may not qualify if:

• Pre-existing cardiac device (i.e. pacemaker/defibrillator)
• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Zheng A, Adam R, Peebles C, Harden S, Shambrook J, Abbas A, Vedwan K, Adam G, Haydock P, Cowburn P, Young C, Long J, Walkden M, Smith S, Greenwood E, Olden P, Flett A. Effect of optimisation to contemporary HFrEF medical therapy with sacubitril/valsartan (Entresto) and dapaglifloziN on left Ventricular reverse remodelling as demonstrated by cardiac magnetic resonance (CMR) Imaging: the ENVI study. Open Heart. 2024 Dec 2;11(2):e002933. doi: 10.1136/openhrt-2024-002933.

  PMID: 39622578 DERIVED

Study Officials

• Andrew S Flett, MBBS BSc MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 27, 2022
• Study Start: June 9, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

GB (1)