HFrEF - Heart Failure With Reduced Ejection FractionHFrEFNCT06717204
Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and Myocardial Infarction (MI), run by Qilu Hospital of Shandong University at 3 sites in China.
Trial summary
The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, Myocardial Infarction (MI)
- What is being tested?
- Vericiguat Oral Tablet [Verquvo] and Prescription Drugs
- Type of treatment
- Pill or oral medicine
- How many people
- 210 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic heart failure with reduced ejection fraction after myocardial infarction
Who may be able to join
- The history of acute myocardial infarction exceeds 3 months;
- Symptoms and signs of heart failure have been stable for more than one month;
- 18 years old or more;
- NYHA cardiac function classified as grade II~IV;
- LVEF≤40%；
- NT-proBNP≥450pg/ml；
- All subjects or their guardians must sign the subject consent before entering the trial.
Who cannot join
- Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
- Mechanical complications of myocardial infarction;
- Unable to obtain primary outcome data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Panpan Hao, MD, PhD, 86-18560086593, panda.how@sdu.edu.cn
Panpan Hao, MD, PhD
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013
Bin Li, MD, PhD, 86-0531-85695114, qingquan0615@163.com
Bin Li, MD, PhD
The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital
Jinan, Shandong, 250031
Zhongwen Zhang, MD, PhD, 86-0531-89268763, zhangzhongwen@sdu.edu.cn
Zhongwen Zhang, MD, PhD
About this study
Official title: Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.
- Being tested
- Vericiguat Oral Tablet [Verquvo], Prescription Drugs
- Keywords
- HFrEF, Myocardial Infarction, Vericiguat
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat Oral Tablet [Verquvo]Drug
Also called Conventional treatment
Vericiguat in addition to conventional treatment
Prescription DrugsDrug
Also called Conventional treatment without vericiguat
Conventional treatment only
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat and conventional treatment | Vericiguat in addition to conventional treatment Receives: Drug: Vericiguat Oral Tablet [Verquvo]; Drug: Prescription Drugs | |
| Conventional treatment only | Conventional treatment only Receives: Drug: Prescription Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEDVI=LVEDV/BSA
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
Measured: From baseline to the end of 12-month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital, Qianfoshan Hospital
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
- Investigators
- Panpan Hao, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717204
- Sponsor's protocol ID
- Vericiguat for HFrEF
- Acronym
- HFrEF
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Institutional policy and patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06717204
- Acronym / sponsor ID
- HFrEF / Vericiguat for HFrEF
- Keywords
- HFrEF, Myocardial Infarction, Vericiguat
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Jinan Central Hospital, Qianfoshan Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat and conventional treatment | – | Drug: Vericiguat Oral Tablet [Verquvo], Drug: Prescription DrugsVericiguat in addition to conventional treatment |
| Conventional treatment only | – | Drug: Prescription DrugsConventional treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic heart failure with reduced ejection fraction after myocardial infarction
Key inclusion criteria (7 listed)
- The history of acute myocardial infarction exceeds 3 months;
- Symptoms and signs of heart failure have been stable for more than one month;
- 18 years old or more;
- NYHA cardiac function classified as grade II~IV;
- LVEF≤40%；
Key exclusion criteria (3 listed)
- Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
- Mechanical complications of myocardial infarction;
- Unable to obtain primary outcome data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vericiguat Oral Tablet [Verquvo]Also: Conventional treatmentVericiguat in addition to conventional treatment | Drug | Vericiguat and conventional treatment |
| Prescription DrugsAlso: Conventional treatment without vericiguatConventional treatment only | Drug | Conventional treatment only, Vericiguat and conventional treatment |
Primary outcome
LVEDVI=LVEDV/BSA
Time frame: From baseline to the end of 12-month treatment
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided. Institutional policy and patient privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panpan Hao, MD, PhD principal investigator
Qilu Hospital of Shandong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and Myocardial Infarction (MI), run by Qilu Hospital of Shandong University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panpan Hao, MD, PhD (86-18560086593, panda.how@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEDVI=LVEDV/BSA (time frame: From baseline to the end of 12-month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.