Back to resultsThe Anti-myocardial Fibrosis Effect of Vericiguat in HFrEF (ANF-HF)
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vericiguat
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring heart failure, myocardial fibrosis, vericiguat
Eligibility Criteria
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.
Sites / Locations
- The first affiliated Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard treatment with vericiguat group
Standard treatment group
Arm Description
HFrEF patients accept standard heart failure medication and Vericiguat therapy
HFrEF patients accept standard medication therapy
Outcomes
Primary Outcome Measures
Extracellular volume [ECV]
Change in Extracellular volume [ECV]measured by cardiac magnetic resonance imaging [CMR]
Secondary Outcome Measures
Left ventricular end-diastolic volume [LV-EDV] index
Change in Left ventricular end-diastolic volume [LV-EDV] index measured by cardiac magnetic resonance imaging
Heart structure and function
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
N-terminal pro-B-type natriuretic peptide [NT-proBNP]
New York Heart Association cardiac function classification
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
Change in left ventricular end-systolic volume [LV-ESV] index measured by cardiac magnetic resonance imaging
myocardial mass index
Change in myocardial mass index measured by cardiac magnetic resonance imaging
relative wall thickness
Change in relative wall thickness measured by cardiac magnetic resonance imaging
epicardial adipose tissue [EAT] thickness
Change in epicardial adipose tissue [EAT] thickness measured by cardiac magnetic resonance imaging
Full Information
NCT ID
NCT05799638
First Posted
March 12, 2023
Last Updated
May 11, 2023
Sponsor
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05799638
Brief Title
The Anti-myocardial Fibrosis Effect of Vericiguat in HFrEF
Acronym
ANF-HF
Official Title
The Anti-myocardial Fibrosis Effect of Vericiguat in Patients With Heart Failure With Reduced Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
heart failure, myocardial fibrosis, vericiguat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment with vericiguat group
Arm Type
Experimental
Arm Description
HFrEF patients accept standard heart failure medication and Vericiguat therapy
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm Description
HFrEF patients accept standard medication therapy
Intervention Type
Drug
Intervention Name(s)
Vericiguat
Intervention Description
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
Primary Outcome Measure Information:
Title
Extracellular volume [ECV]
Description
Change in Extracellular volume [ECV]measured by cardiac magnetic resonance imaging [CMR]
Time Frame
Before and after 3 months of continuous treatment
Secondary Outcome Measure Information:
Title
Left ventricular end-diastolic volume [LV-EDV] index
Description
Change in Left ventricular end-diastolic volume [LV-EDV] index measured by cardiac magnetic resonance imaging
Time Frame
Before and after 3 months of continuous treatment
Title
Heart structure and function
Description
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
Time Frame
Before and after 3 months of continuous treatment
Title
Concentration of circulating biomarkers of heart failure
Description
N-terminal pro-B-type natriuretic peptide [NT-proBNP]
Time Frame
Before and after 3 months of continuous treatment
Title
New York Heart Association cardiac function classification
Description
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
Time Frame
Before and after 3 months of continuous treatment
Title
Left ventricular end-systolic volume [LV-ESV] index
Description
Change in left ventricular end-systolic volume [LV-ESV] index measured by cardiac magnetic resonance imaging
Time Frame
Before and after 3 months of continuous treatment
Title
myocardial mass index
Description
Change in myocardial mass index measured by cardiac magnetic resonance imaging
Time Frame
Before and after 3 months of continuous treatment
Title
relative wall thickness
Description
Change in relative wall thickness measured by cardiac magnetic resonance imaging
Time Frame
Before and after 3 months of continuous treatment
Title
epicardial adipose tissue [EAT] thickness
Description
Change in epicardial adipose tissue [EAT] thickness measured by cardiac magnetic resonance imaging
Time Frame
Before and after 3 months of continuous treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongying Zhang, PhD
Phone
+8613608398395
Email
zdy.chris@qq.com
Facility Information:
Facility Name
The first affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongying Zhang, PhD
Phone
+8613608398395
Email
zdy.chris@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32222134
Citation
Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
Results Reference
background
PubMed Identifier
29650126
Citation
Gonzalez A, Schelbert EB, Diez J, Butler J. Myocardial Interstitial Fibrosis in Heart Failure: Biological and Translational Perspectives. J Am Coll Cardiol. 2018 Apr 17;71(15):1696-1706. doi: 10.1016/j.jacc.2018.02.021.
Results Reference
background
PubMed Identifier
29032136
Citation
Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11.
Results Reference
background
PubMed Identifier
35363499
Citation
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674.
Results Reference
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PubMed Identifier
34447992
Citation
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;:
Results Reference
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The Anti-myocardial Fibrosis Effect of Vericiguat in HFrEF
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