Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatments padn, sham padn, tadalafil
Phase phase 4
Sponsor Nanjing First Hospital, Nanjing Medical University
Start date February 2017
End date April 2020
Trial size 370 participants
Trial identifier NCT02284737, FirstNanjingMU

Summary

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 targets for PAH patients are not clear. We previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH who were unresponsive to target drugs. However, there is a lack of a randomized study to identify the effect of PADN on PAH.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking investigator
Arm
(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.
padn 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.
tadalafil Cialis
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.
(Sham Comparator)
The radiofrequency ablation catheter placed, no ablations.
sham padn sham pulmonary artery denervation
The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
tadalafil Cialis
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.

Primary Outcomes

Measure
Pulmonary artery hypertension (PAH)- related events
time frame: Baseline to month 6

Secondary Outcomes

Measure
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

Eligibility Criteria

All participants at least 18 years old.

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]>2.5 Woods unit. Exclusion Criteria: General exclusion criteria: - Pregnancy and breast feeding mother; - Co-morbidity with an estimated life expectancy of < 50 % at 6 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.

Additional Information

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: PADN-PAH Study
Principal investigator Shao-Liang Chen, MD
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 29% 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 370 PAH patients was required, with 185 patients/per group at a ratio of 1:1 randomization.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Nanjing First Hospital, Nanjing Medical University.