Cardiac Left Atrial Evaluation and Response in HFrEF With Sacubitril/Valsartan

NCT07088471 | Completed

• 1 other identifier: CHB 005/25
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is an increasingly common condition that can have a significant impact on quality of life and reduce life expectancy. In recent decades, a number of drugs have been developed specifically for this condition. One such drug, called Sacubitril/valsartan (SV) has been shown to reduce hospitalizations and prolong life expectancy of patients with heart failure. It works by reversing some of the structural and functional changes to the heart that occur in heart failure. However, not all patients respond to the drug. Further research is needed to better understand the reasons for this and predict who will benefit most from the drug. Left atrial strain is a relatively new measurement that can be obtained using ultrasound imaging of the heart, and it provides objective information about how one of the heart's four chambers is functioning. The investigators aim to assess the effect of SV therapy on left atrial strain in patients with heart failure. The investigator's objective is to understand whether abnormal left atrial strain or changes in left atrial strain help predict response to SV therapy.

Conditions

Heart Failure and Reduced Ejection Fraction

Keywords

left atrial strain; Sacubril/valsartan; HFrEF; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Correlation between pre-therapy left atrial strain parameters on speckle-tracking echocardiography and therapy-associated changes in left ventricular ejection fraction and/or serum NT-pro BNP.

  Correlation between baseline, pre-therapy left atrial strain parameters on speckle-tracking echocardiography (TTE) with therapy-associated changes in left ventricular ejection fraction (LVEF) on TTE and serum NT-pro BNP. LVEF will be assessed on TTE using the modified Simpson's biplane method. Left atrial strain will be assessed using speckle tracking analysis with EchoPAC Software v204 (GE Vingmed Ultrasound AS, Horten, Norway). Correlation will be assessed using Spearman's rank correlation coefficients.

  At least 3-6 months post initiation of SV therapy

Secondary Outcomes (3)

• Correlation between pre-therapy left atrial strain parameters and baseline left ventricular ejection fraction and serum NT-pro BNP level.

  At least 3-6 months post initiation of SV therapy

• Mean change in left atrial strain parameters pre- and post-SV therapy

  At least 3-6 months post initiation of SV therapy

• Correlation between therapy-associated changes in left atrial strain parameters and therapy-associated changes in left ventricular ejection fraction and/or serum NT pro-BNP level.

  At least 3-6 months post initiation of SV therapy

Interventions

Sacubtril/Valsartan DRUG

Angiotensin-receptor blocker and neprilysin inhibitor therapy

Eligibility Criteria

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

Study Population

Heart Failure with reduced ejection fraction (HFrEF) patients on stable guideline-directed medical therapy prior to commencing sacubitril/valsartan (SV) will be retrospectively identified

You may qualify if:

• Adults diagnosed with heart Failure with reduced ejection fraction (HFrEF), i.e. LVEF ≤40% by Simpson's method on transthoracic echocardiography
• Stable guideline-directed medical therapy prior to sacubitril/valsartan (SV) initiation
• New York Heart Association classes II-III symptom status
• Guideline-directed up-titration of SV therapy to the maximum tolerated dose
• Transthoracic echocardiogram and NT-proBNP prior to SV initiation and at 3 months post commencement of therapy

You may not qualify if:

• Patients not in sinus rhythm at time of echocardiograms (precludes left atrial strain analysis)
• Sub-optimal echocardiographic images to allow measurement of left atrial strain
• Prior mitral valve intervention (left atrial strain assessment unreliable in this cohort)
• Severe mitral regurgitation (left atrial strain assessment unreliable in this cohort)

Sponsors & Collaborators

• Connolly Hospital Blanchardstown: lead

Study Sites (1)

Connoly Hospital Blanchardstown

Dublin, Ireland

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IE (1)