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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

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.
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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02284737
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nanjing First Hospital, Nanjing Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Shao-Liang Chen, MD
Principal Investigator Affiliation Nanjing First Hospital, Nanjing Medical University, China
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Additional Details

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.

Arms & Interventions

Arms

Experimental: PADN + sildenafil

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 Comparator: sham PADN + sildenafil

The radiofrequency ablation catheter placed, no ablations.

Interventions

Procedure: - PADN

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.

Procedure: - sham PADN

The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.

Drug: - Sildenafil

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.

Contact a Trial Team

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International Sites

Nanjing First Hospital, Nanjing, Jiangsu, China

Status

Recruiting

Address

Nanjing First Hospital

Nanjing, Jiangsu, 210006

Site Contact

Shaoliang Chen, MD

chmengx@126.com

+86 13605157029

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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