HFpEF - Heart Failure with Preserved Ejection FractionNCT06740539
Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
A study testing Catheter ablation of atrial fibrillation in people with HFpEF - Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site in China.
Trial summary
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFpEF - Heart Failure with Preserved Ejection Fraction, Atrial Fibrillation (AF)
- What is being tested?
- Catheter ablation of atrial fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years.
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）
- Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
- Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.)
- New York Heart Association class II, III, or IV.
Who cannot join
- Previous left heart ablation procedure for AF.
- Contraindication to chronic anticoagulation therapy or heparin.
- Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view.
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
- Planned cardiovascular intervention.
- Listed for heart transplant.
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- Cardiac assist device implanted.
- Life expectancy ≤ 12 months.
- Mental or physical inability to participate in the study.
- Requirement for dialysis due to terminal renal failure.
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
- Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai
Mu Qin, 13052320103, qinmuae@163.com
About this study
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.
- Being tested
- Catheter ablation of atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation of atrial fibrillationProcedure or surgery
Catheter ablation of atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Ablation Group | Experimental | Ablation Group: Received heart failure treatment combined with ablation Receives: Procedure: Catheter ablation of atrial fibrillation |
| Drug Control Group | No intervention | Received heart failure treatment combined with heart rate control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Secondary outcomes (6)
All-Cause Mortality
All deaths and all heart transplants because of terminal heart failure (HF) will be included.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Worsening of Heart Failure Requiring Unplanned Hospitalization
Patients requiring intravenous medication for HF (including diuretics, vasodilators or inotropic agents) or a substantial increase in oral diuretic therapy for HF (i.e., an increase of furosemide ≥40 mg or equivalent, or the addition of a thiazide to a loop diuretic) will be deemed to have worsening of HF. Further, rales and/or S3 sound, chest x-ray, worsening of dyspnea, worsening of peripheral edema and increase of New York Heart Association class will be assessed for determination of worsening of HF.Unplanned hospitalization is defined as any in-hospital stay over one date change, and not planned by the Investigator.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Cardiovascular Mortality
All deaths due to cardiovascular reasons and all heart transplants because of terminal HF. Deaths due to worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events will qualify for this secondary end point.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Unplanned Hospitalization due to Cardiovascular Reason
Any in-hospital stay over one date change due to cardiovascular reason, which includes worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events, and not planned by the Investigator. In case the hospitalization is classified as planned by the Investigator, and the time interval between the decision to hospitalize and the hospitalization is less than 24 hours, the End Point and Adverse Event Committee will give final classification concerning planned or unplanned.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
All-Cause Hospitalization
Any in-hospital stay over one date change.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Cerebrovascular Accident
Cerebrovascular accident, ischemic or hemorrhagic, describes a clinical and neurological syndrome, based on an acute damage of the brain. The common denominator is the sudden onset of a neurological deficit.
Measured: During regular follow-up visits at 3, 6, 12, 24months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure with Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Anhui Medical University, Hefei Second People's Hospital, The Second People's Hospital of Anhui Province, Hefei Binhu Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740539
- Sponsor's protocol ID
- CAPHF-AF
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
- ClinicalTrials.gov ID
- NCT06740539
- Acronym / sponsor ID
- CAPHF-AF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Anhui Medical University, Hefei Second People's Hospital, The Second People's Hospital of Anhui Province, Hefei Binhu Hospital
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 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.
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation Group | Experimental | Procedure: Catheter ablation of atrial fibrillationAblation Group: Received heart failure treatment combined with ablation |
| Drug Control Group | No intervention | –Received heart failure treatment combined with heart rate control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- The patient is willing and able to comply with the protocol and has provided written informed consent.
- Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）
- Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
- Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.)
Key exclusion criteria (12 listed)
- Previous left heart ablation procedure for AF.
- Contraindication to chronic anticoagulation therapy or heparin.
- Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view.
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
- Planned cardiovascular intervention.
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 |
|---|---|---|
| Catheter ablation of atrial fibrillationCatheter ablation of atrial fibrillation | Procedure or surgery | Ablation Group |
Primary outcome
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
6 secondary outcomes
All-Cause Mortality
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Worsening of Heart Failure Requiring Unplanned Hospitalization
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Cardiovascular Mortality
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Unplanned Hospitalization due to Cardiovascular Reason
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
All-Cause Hospitalization
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Cerebrovascular Accident
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation of atrial fibrillation in people with HFpEF - Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site 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 6 inclusion and 12 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 18 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 1 site 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 Mu Qin, Dr (+8613052320103, qinmuae@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF. (time frame: During regular follow-up visits at 3, 6, 12, 24months.). 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 18 Dec 2024.