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Completed

NCT Number: NCT02220335

Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure

A number of 100 patients with pulmonary hypertension associated with the left Heart failure scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either PADN or control group.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Heart Diseases Heart Failure Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

Heart failure patients must have completed the right heart catheterization. All the patients accepted the optimal medical therapies,including diuretics, Nitrate esters, β-blockers, ACE inhibitors or receptor blocker aldosterone antagonists and/or digoxin).The patients of pulmonary hypertension are defined into two groups: "passive" pulmonary hypertension(mPAP≥25 mmHg, PCWP>15 mmHg and pulmonary vascular resistance<3 woods unit) increase due to backward transmission of increased left ventricular filling pressure, "reactive" pulmonary hypertension (mPAP≥25 mmHg, PCWP>15 mmHg and pulmonary vascular resistance >3 woods unit) increase in resistance due to either pulmonary vasoconstriction or structural changes in the pulmonary vasculature.

All the "reactive" pulmonary hypertension patients are eligible for the randomized study in PADN group or control group according to the computer generated random table.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18yr
  • "Reactive"Pulmonary Hypertension in Left Heart Failure: mPAP≥25 mmHg, PCWP>15 mmHg and pulmonary vascular resistance (PVR) [The PVR =(mPAP-PCWP)/ carbon monoxide]>3.0 woods unit
  • Voluntary acceptance of all follow-up assessment of program requirements.

Exclusion criteria

  • WHO group I, III, IV, V pulmonary artery hypertension
  • Severe Renal dysfunction (Ccr<30 ml/min)
  • Blood platelet count<100,000/L
  • Expected life span<12-month
  • In pregnancy
  • Systematical inflammation
  • Malignant cancer(s)
  • Tricuspid valve stenosis, Supra-pulmonary valve stenosis
  • Allergic to studied drugs or metal materials

Treatment and study plan

Pulmonary arterial denervation

Procedure

Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.

Other names: PADN

standard treatment

Drug

Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.

Other names: Diuretics, Nitrate esters, β-blockers, ACE inhibitors or receptor blockers aldosterone antagonists, Digoxin

Primary outcomes

  1. 6-min-walk distance increase

    Time frame: 6 months

    The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.

Secondary outcomes

  1. Pulmonary vascular resistance

    Time frame: 6 months

    Measure pulmonary vascular resistance using 2D doppler echocardiogram w/definity. Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.

Other outcomes

  1. Accuracy of pulmonary embolism

    Time frame: 6 months

    The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following:

    • new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;
    • new perfusion defect of at least 75% on V/Q lung scan;
    • inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography

    Fatal PE is:

    • PE based on objective diagnostic testing or autopsy or
    • death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial

Acronym: PADN-5

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2014
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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