Heart Failure With Preserved Ejection Fraction (HFPEF)CMR-PV HFpEFNCT07326605
Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- How many people
- 5,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Dec 2030
- How long will I take part?
- 36 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with heart failure with preserved ejection fraction experienced cardiac MRI scanning
Who may be able to join
- Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;
- Left ventricular ejection fraction (LVEF) of 50% or higher;
- N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level > 125 pg/mL or brain natriuretic peptide (BNP) level > 35 pg/mL in sinus rhythm, or NT-proBNP level > 365 pg/mL or BNP level > 105 pg/mL in atrial fibrillation;
- At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) > 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) < 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') > 13.
Who cannot join
- Primary cardiomyopathy;
- Acute coronary syndrome;
- Primary severe valvular heart disease;
- Acute pulmonary embolism;
- Severe renal dysfunction;
- Poor image quality that was insufficient to identify myocardial endocardium and epicardium.
About this study
Official title: Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction
This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). This study plans to enroll 3000 adult HFpEF patients and 500 adult healthy controls. The primary clinical endpoint was a composite of all-cause mortality and heart failure hospitalization, with events ascertained through medical records, clinic visits, and telephone follow-up. This study aims to determine whether cardiac MRI-derived PV loop analysis parameters and myocardial energetics provide incremental discriminative and prognostic information beyond conventional cardiac MRI parameters in patients with HFpEF. The study is non-interventional and does not involve any investigational drugs or devices.
- Keywords
- Cardiac MRI, Heart failure with preserved ejection fraction, Pressure loop analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF patients | Heart failure with preserved ejection fraction (HFpEF) patients | |
| Healthy controls | Sex- and age-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with All-Cause Death
All-cause death was defined as death from any cause occurring during the 3-year follow-up period. Mortality status was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.
Measured: 3-year
Secondary outcomes (2)
Number of Participants with Cardiovascular Death
Cardiovascular death was defined as death resulting from cardiovascular causes occurring during the 3-year follow-up period. Cardiovascular causes included, but were not limited to, myocardial infarction, heart failure, fatal arrhythmia, stroke, or sudden cardiac death. The outcome was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.
Measured: 3-year
Number of Participants with Heart Failure Hospitalization
Heart failure hospitalization was defined as any hospitalization for heart failure occurring during the 3-year follow-up period. Hospitalizations were identified based on hospital admission records with a primary diagnosis of heart failure.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2010
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- 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
- 5,500 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326605
- Sponsor's protocol ID
- CMR-PV HFpEF
- Other IDs
- 82471973, 7242110, 3332025134
- Acronym
- CMR-PV HFpEF
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07326605
- Acronym / sponsor ID
- CMR-PV HFpEF / CMR-PV HFpEF
- Keywords
- Cardiac MRI, Heart failure with preserved ejection fraction, Pressure loop analysis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 8 Jan 2026 (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.
This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). This study plans to enroll 3000 adult HFpEF patients and 500 adult healthy controls. The primary clinical endpoint was a composite of all-cause mortality and heart failure hospitalization, with events ascertained through medical records, clinic visits, and telephone follow-up. This study aims to determine whether cardiac MRI-derived PV loop analysis parameters and myocardial energetics provide incremental discriminative and prognostic information beyond conventional cardiac MRI parameters in patients with HFpEF. The study is non-interventional and does not involve any investigational drugs or devices.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF patients | – | –Heart failure with preserved ejection fraction (HFpEF) patients |
| Healthy controls | – | –Sex- and age-matched healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure with preserved ejection fraction experienced cardiac MRI scanning
Key inclusion criteria (4 listed)
- Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;
- Left ventricular ejection fraction (LVEF) of 50% or higher;
- N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level > 125 pg/mL or brain natriuretic peptide (BNP) level > 35 pg/mL in sinus rhythm, or NT-proBNP level > 365 pg/mL or BNP level > 105 pg/mL in atrial fibrillation;
- At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) > 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) < 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') > 13.
Key exclusion criteria (6 listed)
- Primary cardiomyopathy;
- Acute coronary syndrome;
- Primary severe valvular heart disease;
- Acute pulmonary embolism;
- Severe renal dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with All-Cause Death
Time frame: 3-year
All-cause death was defined as death from any cause occurring during the 3-year follow-up period. Mortality status was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.
2 secondary outcomes
Number of Participants with Cardiovascular Death
Time frame: 3-year
Number of Participants with Heart Failure Hospitalization
Time frame: 3-year
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 28 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with All-Cause Death (time frame: 3-year). 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 28 Jan 2026.