Heart Failure With Preserved Ejection FractionPADN-HFpEFNCT07331220
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction
A study testing PADN and GDMT in people with Heart Failure With Preserved Ejection Fraction, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF>40%). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- PADN and GDMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2026to 30 Dec 2028
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
- 2. Both male and female subjects age between 18 ~ 85 years old. 3. Dyspnea on exertion (NYHA functional class II-IV) not explained by non-cardiac or ischemic etiology.
- 4. LVEF >40% on imaging within 24 months prior to enrollment, with no clinical changes suggesting worsening systolic function.
- 5. Elevated NT-proBNP or BNP levels meeting the following thresholds stratified by age and atrial fibrillation (AF) status:
- Patients WITHOUT atrial fibrillation:
- Age <50 years: BNP >100 pg/mL or NT-proBNP >450 pg/mL
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- Age 50-75 years: BNP >150 pg/mL or NT-proBNP >900 pg/mL
- Age >75 years: BNP >200 pg/mL or NT-proBNP >1800 pg/mL
- Patients WITH atrial fibrillation:
- BNP >150 pg/mL or NT-proBNP >300 pg/mL
- 6. Stable HF GDMT (no change in either types or dose) for ≥14 days prior to enrollment, including SGLT2i and spironolactone. Other medication, including angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitor (ARNI, sacubitril/valsartan), beta-blockers, or calcium channel blockers (CCBs), were left at physician's discretion.
- 7. Dose changes of ACEIs, ARBs, sacubitril/valsartan, beta-blockers, or CCBs did not exceed 100% of baseline dose (i.e., no doubling or halving).
- 8. Continuous diuretic use for ≥14 days prior to screening, with stable dose in the last 7 days.
- 9. Meet at least one of the following:
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- Hospitalization for decompensated HF within the past 12 months
- Received intravenous loop diuretic or ultrafiltration for HF within the past 12 months
- Documented resting pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) >15 mmHg, or exercise PCWP ≥25 mmHg, or exercise LVEDP ≥20 mmHg on right heart catheterization within the past 12 months
- Echocardiographic evidence within the past 24 months of left atrial enlargement (LA anterior-posterior diameter male >40 mm, female >38 mm; LA area ≥20 cm², LA volume index ≥29 ml/m²) or left ventricular hypertrophy (interventricular septal thickness or LV posterior wall thickness ≥12 mm).
Who cannot join
- Hospitalization for HF within 7 days prior to screening.
- Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
- History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
- Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
- Hospitalization within 30 days prior to screening for: acute ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina, percutaneous coronary intervention (PCI), or cardiac surgery.
- Cardiac resynchronization therapy (CRT) within 90 days prior to screening.
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- Planned revascularization (PCI or CABG), major cardiac surgery (including coronary artery bypass grafting, valve replacement, ventricular assist device implantation, heart transplantation, other surgery requiring thoracotomy), transcatheter aortic valve replacement (TAVR), or CRT implantation within 90 days after screening.
- History of femoral or jugular vein surgery.
- Life expectancy <1 year at screening.
- Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m² at screening (calculated using the modified MDRD formula).
- BNP <150 pg/ml and NT-proBNP <300 pg/ml at screening.
- Serum potassium >5.5 mmol/L at screening.
- Physical examination showing volume depletion at screening or randomization.
- Mean supine systolic blood pressure <100 mmHg at screening or randomization.
- Uncontrolled hypertension, defined as mean supine systolic blood pressure ≥160 mmHg (average of three measurements) at screening.
- Documented stable-state LVEF <40% within the past 24 months.
- Current active malignancy (excluding non-melanoma skin cancer).
- HF due to specific cardiomyopathies, including: restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular stenosis, hypertrophic obstructive cardiomyopathy (HOCM).
- Chronic obstructive pulmonary disease (COPD) judged as the primary cause of dyspnea.
- Myocardial ischemia judged as the primary cause of dyspnea.
- Isolated right heart failure due to pulmonary disease.
- Complex congenital heart disease.
- History of allergic reaction to guideline-directed HF medications.
- Pregnant/lactating women. Women of childbearing potential (WOCBP) defined as post-menarche and not permanently sterilized (hysterectomy/bilateral tubal ligation) or postmenopausal (natural amenorrhea ≥12 months without other medical cause). Sexually active WOCBP must agree to use medically accepted contraception during the study, including: |surgical sterilization, progestin contraceptives (oral/implant), barrier methods (condom/diaphragm) with spermicide, intrauterine device (IUD). Urine pregnancy test required at each visit; negative result required for continued participation.
- Other exclusion criteria as judged by the investigator, including but not limited to conditions that may jeopardize patient safety during study participation, factors interfering with study data interpretation, or patients unlikely to comply with study procedures/requirements.
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
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Shao-Liang Chen, MD, +86-25-52271351, chmengx@126.com
Jing Kan, PhD, +86-25-52279862, kanjingok@126.com
About this study
To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF>40%). Outcomes include cardiovascular death, HF-related rehospitalization, requirement for heart transplantation or need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Read the detailed description
A randomized, multicenter, blinded, sham-controlled trial in
Subjects with chronic HFpEF (LVEF >40%) meeting inclusion criteria and no exclusion criterion will be enrolled from 25 + centers in China within 24 months. Patients will be randomized 1:1 to:
- Experimental Group: PADN + GDMT
- Control Group: Sham procedure + GDMT
GDMT regimen: Sodium-glucose co-transporter 2 inhibitor (SGLT2i) + Spironolactone. SGLT2i can be dapagliflozin or empagliflozin.
- Dapagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <25 mL/min/1.73 m².
- Empagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <20 mL/min/1.73 m².
- Spironolactone: Starting dose 10-20 mg/day, maximum dose 40 mg/day. Suspend if serum potassium is >5.5 mmol/L; restart at half dose after correction. Permanently discontinue if serum potassium is >6.0 mmol/L. Suspend and evaluate if eGFR persistently declines >30% or <30 mL/min/1.73 m².
Other medications are left at the physician's discretion. The proportion of patients with persistent atrial fibrillation is not to exceed 35%.
- Being tested
- PADN, Sham procedure, GDMT
- Keywords
- Pulmonary artery denervation, Heart failure with preserved ejection fraction, Guideline-directed medical therapy, Clinical worsening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADNProcedure or surgery
Also called Pulmonary artery denervation, Right heart catheterization
Advancing the pulmonary artery denervation catheter with a diameter to vessel of 1.1~1.2:1 through the long sheath to the left pulmonary artery ostium. Connecting the catheter to the RF generator. Rotate the catheter under imaging so the premounted electrodes tightly contact the target ablation positions. Recommended temperature-controlled mode, set temperature to 50°C, ablation time to 150 seconds (with effective ablation time of 120 seconds, defined as the tissue temperature reaches 45°C-55°C. Ablation is performed at a total of 3 sites with 120 seconds for each.
Sham procedureProcedure or surgery
The ablation catheter under imaging guidance will be advanced to the target ablation points, but DO NOT connect the ablation catheter to the RF generator; DO NOT deliver RF energy. The operator issues commands to "start" and "stop" RF ablation, simulating the sound of the PADN RF generator for at least 2 minutes (using a pre-recorded MP4).
GDMTDrug
Also called Guideline-directed medical therapy
GDMT regimen including sodium-glucose co-transporter 2 inhibitor (SGLT2i) + spironolactone. SGLT2i can be dapagliflozin or empagliflozin.
- Dapagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <25 mL/min/1.73 m².
- Empagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <20 mL/min/1.73 m².
- Spironolactone: Starting dose 10-20 mg/day, maximum dose 40 mg/day. Suspend if serum potassium is >5.5 mmol/L; restart at half dose after correction. Permanently discontinue if serum potassium is >6.0 mmol/L. Suspend and evaluate if eGFR persistently declines >30% or <30 mL/min/1.73 m².
Other medications are left at the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| PADN plus GDMT | Experimental | Pulmonary artery denervation combined with guideline-directed medical therapy. Receives: Procedure: PADN; Drug: GDMT |
| Sham procedure plus GDMT | Placebo comparator | Sham procedure combined with guideline-directed medical therapy Receives: Procedure: Sham procedure; Drug: GDMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
A composite of clinical worsening at 12 months, including cardiovascular death, HF-related rehospitalization, requirement for heart transplantation, need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Measured: From randomization to 12 months
Secondary outcomes (13)
Clinical worsening
A composite of clinical worsening at 24 months, including cardiovascular death, HF-related rehospitalization, requirement for heart transplantation, need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Measured: From baseline to 24 months
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) is a percentage-based health index ranging from 0 to 100, where higher scores indicate better heart failure-related health status.
Measured: From baseline to 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels at 1 month, 6 months, and 12 months.
Measured: From baseline to 1 month, 6 months, and 12 months
6-minute walk distance (6MWD)
The 6-minute walk test in patients with chronic heart failure is clinically graded as follows: A distance of less than 150 meters indicates severe heart failure with poor prognosis; 150 to 300 meters corresponds to moderate heart failure; 300 to 450 meters reflects mild heart failure; and a distance greater than 450 meters suggests near-normal cardiac function and a relatively better clinical status.
Measured: From baseline to 1 month, 6 months, and 12 months
KCCQ-CSS increase ≥6 points
The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) is a percentage-based health index ranging from 0 to 100, where higher scores indicate better heart failure-related health status.
Measured: From baseline to 12 months
NT-proBNP reduction ≥20%
Proportion of patients with NT-proBNP reduction ≥20% at 6, 12 months
Measured: From baseline to 6 months and 12 months
KCCQ-CSS increase ≥6 points and NT-proBNP reduction ≥20%
KCCQ-CSS and NT-proBNP will be combined to report heart failure-related health status.
Measured: From baseline to 6 months and 12 months
Echocardiographic parameters (chamber size, systolic and diastolic function)
Echocardiographic parameters, such as left ventricular ejection fraction (LVEF), ventricular volumes, and diastolic function indices (e.g., E/e' ratio), serve as key quantitative endpoints to evaluate cardiac remodeling and therapeutic response.
Measured: From baseline to 6 months
Rate of worsening in outpatients
requiring intravenous injection of medicines, or needing diuretic intensification (including increase in types or doses of diuretics).
Measured: Within 12 months
Rate of heart or lung transplantation
For patients with progressive heart failure
Measured: within 12 months
Rate of left ventricular assist device implantation
Incidence of left ventricular assist device (LVAD) implantation, defined as the proportion of patients undergoing LVAD surgery during the study follow-up period.
Measured: Within 12 months
Requirement of pacemaker / physiologic pacing / CRT / ICD/valvular treatment
Indications for pacemaker: Symptomatic sinus node dysfunction, High-grade AV block (Mobitz II or complete heart block), and Post-TAVI or post-MI advanced conduction disease when persistent.
Indications for CRT: LVEF ≤35%, Sinus rhythm, LBBB morphology, QRS ≥150 ms, NYHA II-III or ambulatory IV, or others (determined by EP team).
Indications for valvular treatment: Aortic Stenosis (AS), Aortic Regurgitation (AR) with Symptoms or Asymptomatic but LVEF ≤55% and/or progressive LV dilation, Primary (degenerative) Mitral Regurgitation (MR) Symptoms or LV dysfunction developing (LVEF ≤60%, Tricuspid Regurgitation (TR), Mitral Stenosis (MS), or others.
Measured: Within 12 months
All events within 24 months
All patients will be followed-up until 24 months
Measured: Within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (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 FractionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to undergo either PADN plus GDMT or sham procedure plus GDMT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Medical University
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331220
- Sponsor's protocol ID
- KY20250425-06
- Acronym
- PADN-HFpEF
- Status last verified
- May 2026
- First submitted
- 8 Dec 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DATA sharing could be accepted upon other researchers reached out to the PI of this trial, with approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT07331220
- Acronym / sponsor ID
- PADN-HFpEF / KY20250425-06
- Keywords
- Pulmonary artery denervation, Heart failure with preserved ejection fraction, Guideline-directed medical therapy, Clinical worsening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Medical University
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 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.
To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF>40%). Outcomes include cardiovascular death, HF-related rehospitalization, requirement for heart transplantation or need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Detailed description
A randomized, multicenter, blinded, sham-controlled trial in
Subjects with chronic HFpEF (LVEF >40%) meeting inclusion criteria and no exclusion criterion will be enrolled from 25 + centers in China within 24 months. Patients will be randomized 1:1 to:
- Experimental Group: PADN + GDMT
- Control Group: Sham procedure + GDMT
GDMT regimen: Sodium-glucose co-transporter 2 inhibitor (SGLT2i) + Spironolactone. SGLT2i can be dapagliflozin or empagliflozin.
- Dapagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <25 mL/min/1.73 m².
- Empagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <20 mL/min/1.73 m².
- Spironolactone: Starting dose 10-20 mg/day, maximum dose 40 mg/day. Suspend if serum potassium is >5.5 mmol/L; restart at half dose after correction. Permanently discontinue if serum potassium is >6.0 mmol/L. Suspend and evaluate if eGFR persistently declines >30% or <30 mL/min/1.73 m².
Other medications are left at the physician's discretion. The proportion of patients with persistent atrial fibrillation is not to exceed 35%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to undergo either PADN plus GDMT or sham procedure plus GDMT
| Arm | Type | Receives |
|---|---|---|
| PADN plus GDMT | Experimental | Procedure: PADN, Drug: GDMTPulmonary artery denervation combined with guideline-directed medical therapy. |
| Sham procedure plus GDMT | Placebo comparator | Procedure: Sham procedure, Drug: GDMTSham procedure combined with guideline-directed medical therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
- 2. Both male and female subjects age between 18 ~ 85 years old. 3. Dyspnea on exertion (NYHA functional class II-IV) not explained by non-cardiac or ischemic etiology.
- 4. LVEF >40% on imaging within 24 months prior to enrollment, with no clinical changes suggesting worsening systolic function.
- 5. Elevated NT-proBNP or BNP levels meeting the following thresholds stratified by age and atrial fibrillation (AF) status:
- Patients WITHOUT atrial fibrillation:
Key exclusion criteria (25 listed)
- Hospitalization for HF within 7 days prior to screening.
- Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
- History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
- Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
- Hospitalization within 30 days prior to screening for: acute ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina, percutaneous coronary intervention (PCI), or cardiac surgery.
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 |
|---|---|---|
| PADNAlso: Pulmonary artery denervation, Right heart catheterizationAdvancing the pulmonary artery denervation catheter with a diameter to vessel of 1.1~1.2:1 through the long sheath to the left pulmonary artery ostium. Connecting the catheter to the RF generator. Rotate the catheter under imaging so the premounted electrodes tightly contact the target ablation positions. Recommended temperature-controlled mode, set temperature to 50°C, ablation time to 150 seconds (with effective ablation time of 120 seconds, defined as the tissue temperature reaches 45°C-55°C. Ablation is performed at a total of 3 sites with 120 seconds for each. | Procedure or surgery | PADN plus GDMT |
| Sham procedureThe ablation catheter under imaging guidance will be advanced to the target ablation points, but DO NOT connect the ablation catheter to the RF generator; DO NOT deliver RF energy. The operator issues commands to "start" and "stop" RF ablation, simulating the sound of the PADN RF generator for at least 2 minutes (using a pre-recorded MP4). | Procedure or surgery | Sham procedure plus GDMT |
| GDMTAlso: Guideline-directed medical therapyGDMT regimen including sodium-glucose co-transporter 2 inhibitor (SGLT2i) + spironolactone. SGLT2i can be dapagliflozin or empagliflozin. * Dapagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <25 mL/min/1.73 m². * Empagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently <20 mL/min/1.73 m². * Spironolactone: Starting dose 10-20 mg/day, maximum dose 40 mg/day. Suspend if serum potassium is >5.5 mmol/L; restart at half dose after correction. Permanently discontinue if serum potassium is >6.0 mmol/L. Suspend and evaluate if eGFR persistently declines >30% or <30 mL/min/1.73 m². Other medications are left at the physician's discretion. | Drug | PADN plus GDMT, Sham procedure plus GDMT |
Primary outcome
Clinical worsening
Time frame: From randomization to 12 months
A composite of clinical worsening at 12 months, including cardiovascular death, HF-related rehospitalization, requirement for heart transplantation, need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
13 secondary outcomes
Clinical worsening
Time frame: From baseline to 24 months
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame: From baseline to 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: From baseline to 1 month, 6 months, and 12 months
6-minute walk distance (6MWD)
Time frame: From baseline to 1 month, 6 months, and 12 months
KCCQ-CSS increase ≥6 points
Time frame: From baseline to 12 months
NT-proBNP reduction ≥20%
Time frame: From baseline to 6 months and 12 months
KCCQ-CSS increase ≥6 points and NT-proBNP reduction ≥20%
Time frame: From baseline to 6 months and 12 months
Echocardiographic parameters (chamber size, systolic and diastolic function)
Time frame: From baseline to 6 months
Rate of worsening in outpatients
Time frame: Within 12 months
Rate of heart or lung transplantation
Time frame: within 12 months
Rate of left ventricular assist device implantation
Time frame: Within 12 months
Requirement of pacemaker / physiologic pacing / CRT / ICD/valvular treatment
Time frame: Within 12 months
All events within 24 months
Time frame: Within 24 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 27 May 2026.
- Individual participant dataSharing planned: Yes. DATA sharing could be accepted upon other researchers reached out to the PI of this trial, with approval.
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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.
Shao-Liang Chen, MD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PADN and GDMT in people with Heart Failure With Preserved Ejection Fraction, run by Nanjing First Hospital, Nanjing Medical University 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 19 inclusion and 25 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 27 May 2026. 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. Some participants in this study may receive a placebo. 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 Shao-Liang Chen, MD (+86-25-52271351, chmengx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: From randomization to 12 months). 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 27 May 2026.