Evaluating a new treatment for pulmonary hypertension linked to heart failure

Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure: a Pilot Study

This study is testing a new procedure called pulmonary artery denervation to see if it can safely help people with heart failure and a specific type of high blood pressure in the lungs feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Pulnovo Medical (Wuxi) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Lisbon)
• Trial ID: NCT05996562 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the safety and efficacy of pulmonary artery denervation (PADN) in patients suffering from combined post- and pre-capillary pulmonary hypertension associated with chronic heart failure. Participants aged 18 to 85 who have been clinically stable and on guideline-directed medical therapy for at least one month will undergo the PADN procedure. They will be monitored for one year to evaluate the treatment's effectiveness and safety. The study focuses on patients with specific pulmonary pressure measurements and heart failure classifications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with confirmed pulmonary hypertension and chronic heart failure who have been stable on medical therapy.

Not a fit: Patients with severe heart failure requiring intensive medical management or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with pulmonary hypertension and chronic heart failure, potentially improving their quality of life.

How similar studies have performed: While the approach of pulmonary artery denervation is relatively novel, similar interventions have shown promise in treating pulmonary hypertension in other contexts.

Eligibility criteria

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.

Where this trial is running

Lisbon

• Hospital de Santa Marta — Lisbon, Portugal (Recruiting)

Study contacts

• Study coordinator: Ruben Ramos, Doctor

Conditions Pulmonary Hypertension; Heart Failure; Pulmonary Artery Denervation; PADN