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Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure (PADN-5)

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ClinicalTrials.gov Identifier: NCT02220335
Recruitment Status : Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Procedure: Pulmonary arterial denervation Drug: Standard treatment Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial
Actual Study Start Date : August 8, 2014
Actual Primary Completion Date : June 16, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulmonary Arterial Denervation (PADN)
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 ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes were tightly in contact with the endovascular surface. About four to eight ablations at 10 W for 60 seconds each were performed in ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.
Procedure: Pulmonary arterial denervation
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 Name: PADN

Drug: Standard treatment
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

Active Comparator: Standard treatment
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.
Drug: Standard treatment
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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:

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

    Fatal PE is:

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220335


Locations
China, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
Principal Investigator: Shaoliang Chen, MD The First Affiliated Hospital with Nanjing Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02220335     History of Changes
Other Study ID Numbers: 20140618
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:
pulmonary hypertension
pulmonary arterial denervation
left heart failure
6-min walk distance

Additional relevant MeSH terms:
Hypertension
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents