ANF-HF: The Anti-myocardial Fibrosis Effect of Vericiguat in HFrEF

Sponsor

Chongqing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799638

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), in the latest trial, it met the expectation to reduce incidence of death from cardiovascular causes or hospitalization for heart failure among HFrEF patients. Myocardial fibrosis as a pathological change in heart failure, it contributes to left ventricular dysfunction leading to development of the disease, experimental studies have showed the potential prevention, or even reversal effect of sGC stimulators in left ventricular hypertrophy and fibrosis. Our study is a prospective controlled clinical trial aim to verify the anti-myocardial fibrosis effect of vericiguat in heart failure with reduced ejection fraction.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Reduced Ejection Fraction	Drug: Vericiguat	Phase 4

Detailed Description

In this trial, the investigators will recruit 60 participants diagnosed with HFrEF (NYHA class II-IV) and assign participants to two groups to receive standard medication therapy with or without vericiguat (target 5mg qd) for 3 months. Before and after the 3-month medication therapy, patients will receive cardiac magnetic resonance (CMR) assessment. The primary endpoint is the change in extracellular volume (ECV) measured by CMR.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Anti-myocardial Fibrosis Effect of Vericiguat in Patients With Heart Failure With Reduced Ejection Fraction

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard treatment with vericiguat group HFrEF patients accept standard heart failure medication and Vericiguat therapy	Drug: Vericiguat Standard HFrEF medication therapy according to the AHA and ESC guidelines and continuous vericiguat treatment for 12 weeks. Vericiguat will be started at 2.5 mg once daily and up-titrated to 5 mg at week 3, to 10 mg at week 5
No Intervention: Standard treatment group HFrEF patients accept standard medication therapy

Arm

Intervention/Treatment

Experimental: Standard treatment with vericiguat group

HFrEF patients accept standard heart failure medication and Vericiguat therapy

Drug: Vericiguat

Standard HFrEF medication therapy according to the AHA and ESC guidelines and continuous vericiguat treatment for 12 weeks. Vericiguat will be started at 2.5 mg once daily and up-titrated to 5 mg at week 3, to 10 mg at week 5

No Intervention: Standard treatment group

HFrEF patients accept standard medication therapy

Outcome Measures

Primary Outcome Measures

Extracellular volume [ECV] [Before and after 3 months of continuous treatment]
Change in Extracellular volume [ECV]measured by cardiac magnetic resonance imaging [CMR]

Secondary Outcome Measures

Left ventricular end-diastolic volume [LV-EDV] index [Before and after 3 months of continuous treatment]
Change in Left ventricular end-diastolic volume [LV-EDV] index measured by cardiac magnetic resonance imaging
Heart structure and function [Before and after 3 months of continuous treatment]
Change in left ventricular end-diastolic [LVD] dimension, left ventricular end-systolic [LVS] dimension, left atrial dimension [LAD] and pulmonary artery systolic pressure [PASP] measured by echocardiogram
Concentration of circulating biomarkers of heart failure [Before and after 3 months of continuous treatment]
N-terminal pro-B-type natriuretic peptide [NT-proBNP]
New York Heart Association cardiac function classification [Before and after 3 months of continuous treatment]
NYHA cardiac function is graded from I to IV to estimate the cardiac function, the higher grade means the worse cardiac function and worse prognosis
Left ventricular end-systolic volume [LV-ESV] index [Before and after 3 months of continuous treatment]
Change in left ventricular end-systolic volume [LV-ESV] index measured by cardiac magnetic resonance imaging
myocardial mass index [Before and after 3 months of continuous treatment]
Change in myocardial mass index measured by cardiac magnetic resonance imaging
relative wall thickness [Before and after 3 months of continuous treatment]
Change in relative wall thickness measured by cardiac magnetic resonance imaging
epicardial adipose tissue [EAT] thickness [Before and after 3 months of continuous treatment]
Change in epicardial adipose tissue [EAT] thickness measured by cardiac magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years who agreed to join in and signed the informed consent.
Diagnosed with HFrEF according to the 2022 AHA guidelines of 2022 AHA/ACC/HFSA guideline and 2021 ESC guideline for the chronic heart failure.
Left ventricular ejection fraction ≤45% measured by CMR or echocardiogram.
NYHA classes II - IV

Exclusion Criteria:

Patients who are receiving phosphodiesterase type 5 (PDE5) inhibitors or other sGC stimulators therapy.
LVEF measured by the UCG >45%.
Contraindication to CMR.
History of allergic or hypersensitivity to drugs involved in the trial or Congenital glucose-galactose intolerance.
Patients with a known history of cancer, angioedema.
Patients with rheumatic valvular heart disease and significant congenital heart disease.
Patients diagnosed with Hypertrophic obstructive cardiomyopathy, myocarditis, Fabry disease, amyloidosis, sarcoidosis, or pericardial disease.
Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for Percutaneous coronary intervention (PCI) or CABG at the trial start.
Interstitial lung disease , severe chronic obstructive pulmonary disease (COPD) and chronic thrombotic pulmonary disease.
SBP≥180mmHg or DBP≥120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.
Pregnant woman.
Chronic kidney disease and eGFR≤30ml/min/1.73m² or accepting long-term hemodialysis.
Hepatic insufficiency classified as Child-Pugh B or C.
Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.
Patients with pacemaker.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated Hospital of Chongqing Medical University	Chongqing		China	400042

Sponsors and Collaborators

Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Dongying Zhang, Professor, Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05799638

Other Study ID Numbers:

2023-01

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dongying Zhang, Professor, Chongqing Medical University

heart failure

myocardial fibrosis

vericiguat

Additional relevant MeSH terms:

Heart Failure

Fibrosis

Study Results

No Results Posted as of Apr 5, 2023