Suspended

ARNICFHARNI's Impact on Cardiac Fibrosis in HFpEF Patients: A Randomized Controlled Trial

Study Aim

This phase 2 study aims to evaluate the impact of ARNI treatment on cardiac fibrosis, specifically focusing on the measurement of Extracellular volume (ECV) in patients with Heart Failure with preserved Ejection Fraction (HFpEF).

What is being tested

Angiotensin Receptor-Neprilysin Inhibition

+ Placebo

Drug

Who is being recruted

Over 45 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: November 2021

See protocol details

Summary

Principal SponsorChongqing Medical University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2021

Actual date on which the first participant was enrolled.

Heart failure with preserved ejection fraction (HFpEF) is a condition where the heart's pumping function is normal, but the heart muscles are stiff, leading to half of all heart failure cases. Currently, effective treatment options for HFpEF are limited. The PARAGON-HF trial showed that a medication called Angiotensin Receptor-Neprilysin Inhibition (ARNI), specifically sacubitril-valsartan, may benefit HFpEF management. However, the impact of ARNI on heart scarring (cardiac fibrosis) in HFpEF remains unknown. This study aims to fill this gap by evaluating ARNI's effect on cardiac fibrosis in HFpEF patients, potentially paving the way for improved care. In this study, 60 HFpEF patients with specific heart function and natriuretic peptide levels will be randomly assigned to receive either sacubitril-valsartan or a placebo. The primary focus is measuring changes in the heart's extracellular volume (ECV) using cardiac magnetic resonance (CMR). Secondary outcomes include assessing exercise capacity through a 6-minute walking test, quality of life via a questionnaire (KCCQ), hospitalizations due to heart failure, heart attacks, and death. This study helps understand ARNI's role in managing HFpEF and its associated heart scarring.

Official TitleThe Effect of Angiotensin Receptor-Neprilysin Inhibition on Cardiac Fibrosis in Patients With HFpEF: A Randomized Controlled Trial

NCT05089539

Principal SponsorChongqing Medical University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

Signed and dated written informed consent

Age ≥ 45 years at time of screening

Preserved systolic left ventricular function, defined by left ventricular ejection fraction (LVEF) ≥ 50%

NYHA classes II-IV

Show More Criteria

13 exclusion criteria prevent from participating

Any prior echocardiographic measurement of LVEF <45%

Patients with a known history of angioedema

History of hypersensitivity to ARNI

Significant congenital heart disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Sacubitril/valsartan (ARNI, 100mg bid)

Group II

Placebo

placebo (100mg bid)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The first affiliated Hospital of Chongqing Medical University

Chongqing, ChinaOpen The first affiliated Hospital of Chongqing Medical University in Google Maps

SuspendedOne Study Center