Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure（PADN-CpcPH-PILOT）

Not Applicable

Recruiting

• Conditions: Pulmonary Hypertension; Heart Failure
• Interventions: Procedure: Pulmonary Artery Denervation

• Registration Number: NCT05996562
• Lead Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.

Brief Summary

The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure.

Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-13
• Study First Posted: 2023-08-18
• Study Start: 2024-06-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age ≥18, ≤85 years;

2. PH must be confirmed by RHC, defined as:

   1. Mean pulmonary arterial pressure (mPAP) > 20mmHg, and;
   2. Pulmonary capillary wedge pressure (PCWP) >15mmHg.

3. Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;

4. Clinically stable HF for at least 1 month, defined as:

   1. No need of intravenous diuretics, inotropes or vasodilators, and
   2. Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and
   3. Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence of atrial fibrillation) on the day of the procedure.

5. NYHA class II-IVa;

6. 6MWD ≥ 100 m and ≤ 450 m;

7. NT-proBNP >125pg/mL (or BNP > 35pg/mL);

8. Understand and be willing to sign informed consent and be strictly willing to follow the protocol.

Exclusion Criteria

1. Any of the following:

   1. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
   2. Pericardial disease; or
   3. Infiltrative or inflammatory myocardial disease; or
   4. Valvular heart disease with stenosis or with severe regurgitation; or
   5. Active endocarditis; or
   6. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
   7. Congenital heart disease; or
   8. Having received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
   9. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted less than 6 months or are anticipated to be implanted within 6 months; or
   10. Anticipated to undergo ablation of atrial fibrillation within 6 months; or
   11. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
   12. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)

2. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;

3. Anticipated to undergo any surgery within the next 6 months;

4. Cardiac index (CI) measured by RHC < 1.5L/min/m2;

5. Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula);

6. Severe liver insufficiency (Child-Pugh classification B-C);

7. Platelet count < 50 × 109/L;

8. Life expectancy < 1 year;

9. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;

10. Active infection requiring oral or intravenous antibiotics;

11. Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;

12. Body mass index (BMI) > 40 kg/m²;

13. Pregnant or lactating women, or planning to be pregnant within one year;

14. Participation in other clinical trials within 3 months prior to signing the informed consent;

15. Any other circumstances that investigators deemed inappropriate to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Artery Denervation (PADN)	Pulmonary Artery Denervation	-

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD) difference	6 months	The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.

Trial Locations

Locations (1)

Hospital de Santa Marta; 🇵🇹 Lisbon, Portugal