Pulmonary Arterial HypertensionPhase 4PADN-PAHNCT02284737

A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH

A Phase 4 study testing PADN and Sildenafil in people with Pulmonary Arterial Hypertension, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: PADN and Sildenafil
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: 28 Nov 2014to 30 Jul 2021
Phase: Phase 4
Are there results?: None posted in the registry

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

Provision of informed consent prior to any study specific procedures;
Men and women 18 years and older;
Group I PAH, defined as a mPAP≥25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.

Who cannot join

General exclusion criteria:
Pregnancy and breast feeding mother;
Estimated life expectancy <12 months;
Scheduled major surgery in the next 6 months;
Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.

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Procedural exclusion criteria:
WHO group II, III, IV, V PH
Severe Renal dysfunction (Ccr<30 ml/min)
Blood platelet count<100,000/L
Expected life span<6-month
Systematical inflammation
Malignant cancer(s)
Tricuspid valve stenosis, Supra-pulmonary valve stenosis
Allergic to studied drugs or metal materials.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing First Hospital
Nanjing, Jiangsu, 210006

Other trials in China

About this study

Official title: A Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery Hypertension

Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of progressive and severe right ventricular failure. Target drugs are reported to be associated with significant improvement of clinical outcome for PAH patients. However, previous studies using those target drugs focused on the change of 6-minute walk distance (6MWD) and or hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical worsening, TTCW), benefits from target drugs for PAH patients are not clear. We previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH patients who were unresponsive to target drugs. Hence, we design the randomized study to identify the effect of PADN on PAH.

Read the detailed description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of PADN on PAH patients. Based on the previous studies, the rate of pulmonary arterial hypertension (PAH)-related event was around 30% after 6-month treatment using target drugs. And our previous data showed that this PAH-related event at 6-month after PADN procedure was 15%. As a result, a total of 270 PAH patients was required, with 135 patients/per group at a ratio of 1:1 randomization. All patients underwent an 18F-DOPA PET/CT scan of pulmonary arteries and the heart, performed at basement.

Conditions: Pulmonary Arterial Hypertension
Being tested: PADN, sham PADN, Sildenafil
Keywords: Pulmonary arterial hypertension
Medical subject headings: Pulmonary Arterial Hypertension

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
Contrast pulmonary artery angiography is performed to localize the pulmonary artery bifurcation level and to calculate the PA diameter. Once the anatomy is deemed acceptable, the radiofrequency ablation catheter is introduced into the distal bifurcation area of the main PA. The catheter is then maneuvered within the PA to allow energy delivery to ensure that the electrodes are tightly in contact with the endovascular surface. Two to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA.
sham PADNProcedure or surgery
Also called sham pulmonary artery denervation
The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
SildenafilDrug
Also called Viagra
Participants initially received 5 mg tadalafil for the first 2 weeks in the two groups. The tadalafil dose may have been up titrated to 40 mg after 2 weeks, with maximum effects being obtained. The up titrated of tadalafil to 40 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.

Study groups in NCT02284737
Study group	Role	What they receive
PADN + sildenafil	Experimental	Two to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA. Receives: Procedure: PADN; Drug: Sildenafil
sham PADN + sildenafil	Sham comparator	The radiofrequency ablation catheter placed, no ablations. Receives: Procedure: sham PADN; Drug: Sildenafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary artery hypertension (PAH)- related events
Including all-cause death, lung transplantation, atrial septostomy, worsening of PAH, initiation of treatment with intravenous or subcutaneous prostacyclin
Measured: Baseline to month 6

Secondary outcomes (11)

6-minute walk distance
The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).
Measured: Baseline to month 6
Pulmonary arterial pressure
Pulmonary arterial pressure was obtained with a 7-F flow-directed Swan-Ganz catheter at end-expiration.
Measured: Baseline to month 6
Right atrial pressure
Right atrial pressure was obtained with a 7-F flow-directed Swan-Ganz catheter at end-expiration.
Measured: Baseline to month 6
Pulmonary Vascular Resistance
PVR=[mean pulmonary arterial pressure-pulmonary artery occlusion pressure] / cardiac output
Measured: Baseline to month 6
Cardiac output
The amount of blood the heart pumps through the circulatory system in a minute. Measured by right heart catheterization.
Measured: Baseline to month 6
Trans-pulmonary pressure gradient
The transpulmonary pressure gradient (TPG), defined by the difference between mean pulmonary arterial pressure (P(pa)) and left atrial pressure (P(la).
Measured: Baseline to month 6
Diastolic pressure gradient
The diastolic pressure gradient (DPG), defined by the difference between mean pulmonary arterial pressure and PA occlusion pressure.
Measured: Baseline to month 6
Pulmonary arterial compliance
Pulmonary arterial compliance was obtained with a 7-F flow-directed Swan-Ganz catheter.
Measured: Baseline to month 6
Borg Dyspnea Index
Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).
Measured: Baseline to month 6
World Health Organization (WHO) Functional Class
WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.
Measured: Baseline to month 6
New York functional class
NYHA Classes: I) Patients with no limitation of activities; they suffer no symptoms from ordinary activities. II) Patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion. III) Patients with marked limitation of activity; they are comfortable at rest. IV) Patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
Measured: Baseline to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201430 Jul 2021

First posted6 Nov 2014 (estimated)
Study start28 Nov 2014
Primary completion30 Jul 2021
Study completion30 Jul 2021

Why it stopped: Lack of subjects.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284737
Sponsor's protocol ID: FirstNanjingMU
Acronym: PADN-PAH
Status last verified: Feb 2024
First submitted: 28 Oct 2014
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.
PubMed 23850902
Chen SL, Zhang YJ, Zhou L, Xie DJ, Zhang FF, Jia HB, Wong SS, Kwan TW. Percutaneous pulmonary artery denervation completely abolishes experimental pulmonary arterial hypertension in vivo. EuroIntervention. 2013 Jun 22;9(2):269-76. doi: 10.4244/EIJV9I2A43.
PubMed 23466961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery Hypertension
ClinicalTrials.gov ID: NCT02284737
Acronym / sponsor ID: PADN-PAH / FirstNanjingMU
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of subjects.
Enrolment: 100 participants (actual)
Lead sponsor: Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
Study start: 28 Nov 2014 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 6 Nov 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
PADN + sildenafil	Experimental	Procedure: PADN, Drug: SildenafilTwo to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA.
sham PADN + sildenafil	Sham comparator	Procedure: sham PADN, Drug: SildenafilThe radiofrequency ablation catheter placed, no ablations.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of informed consent prior to any study specific procedures;
Men and women 18 years and older;
Group I PAH, defined as a mPAP≥25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.

Key exclusion criteria (15 listed)

Pregnancy and breast feeding mother;
Estimated life expectancy <12 months;
Scheduled major surgery in the next 6 months;
Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.

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 denervationContrast pulmonary artery angiography is performed to localize the pulmonary artery bifurcation level and to calculate the PA diameter. Once the anatomy is deemed acceptable, the radiofrequency ablation catheter is introduced into the distal bifurcation area of the main PA. The catheter is then maneuvered within the PA to allow energy delivery to ensure that the electrodes are tightly in contact with the endovascular surface. Two to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA.	Procedure or surgery	PADN + sildenafil
sham PADNAlso: sham pulmonary artery denervationThe radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.	Procedure or surgery	sham PADN + sildenafil
SildenafilAlso: ViagraParticipants initially received 5 mg tadalafil for the first 2 weeks in the two groups. The tadalafil dose may have been up titrated to 40 mg after 2 weeks, with maximum effects being obtained. The up titrated of tadalafil to 40 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.	Drug	PADN + sildenafil, sham PADN + sildenafil

Primary outcome

Pulmonary artery hypertension (PAH)- related events
Time frame: Baseline to month 6
Including all-cause death, lung transplantation, atrial septostomy, worsening of PAH, initiation of treatment with intravenous or subcutaneous prostacyclin

11 secondary outcomes

6-minute walk distance
Time frame: Baseline to month 6
Pulmonary arterial pressure
Time frame: Baseline to month 6
Right atrial pressure
Time frame: Baseline to month 6
Pulmonary Vascular Resistance
Time frame: Baseline to month 6
Cardiac output
Time frame: Baseline to month 6
Trans-pulmonary pressure gradient
Time frame: Baseline to month 6
Diastolic pressure gradient
Time frame: Baseline to month 6
Pulmonary arterial compliance
Time frame: Baseline to month 6
Borg Dyspnea Index
Time frame: Baseline to month 6
World Health Organization (WHO) Functional Class
Time frame: Baseline to month 6
New York functional class
Time frame: Baseline to month 6

Results and safety

The study was stopped early (reason given: Lack of subjects.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Background: PubMed 23850902Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.
Background: PubMed 23466961Chen SL, Zhang YJ, Zhou L, Xie DJ, Zhang FF, Jia HB, Wong SS, Kwan TW. Percutaneous pulmonary artery denervation completely abolishes experimental pulmonary arterial hypertension in vivo. EuroIntervention. 2013 Jun 22;9(2):269-76. doi: 10.4244/EIJV9I2A43.
Individual participant dataSharing planned: No

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
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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. This study is not recruiting at the moment.

Shao-Liang Chen, MD principal investigator

Nanjing First Hospital, Nanjing Medical University, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PADN and Sildenafil in people with Pulmonary Arterial Hypertension, 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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 20 Feb 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. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of subjects.). Results are not available in the source record.

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?

Pulmonary artery hypertension (PAH)- related events (time frame: Baseline to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02284737, which also lists 2 linked publications.

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 20 Feb 2024.