Actively Recruiting
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Led by Pulnovo Medical (Wuxi) Co., Ltd. · Updated on 2024-09-20
264
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
P
Pulnovo Medical (Wuxi) Co., Ltd.
Lead Sponsor
T
The General Hospital of Northern Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
CONDITIONS
Official Title
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with chronic heart failure for at least 3 months
- Received guideline-directed medical therapy for heart failure for at least 1 month
- Clinically stable with no intravenous diuretics, inotropes, or vasodilators for at least 1 month
- Systolic blood pressure between 100 and 160 mmHg and resting heart rate between 50 and 100 bpm (less than 110 bpm for atrial fibrillation) on the day of procedure
- New York Heart Association class II to IVa
- Six-minute walking distance between 100 and 450 meters
- NT-proBNP greater than 125 pg/mL (or BNP greater than 35 pg/mL)
- Hemodynamic measures by right heart catheterization showing mean pulmonary arterial pressure over 20 mmHg and pulmonary capillary wedge pressure over 15 mmHg
- Able to understand and willing to sign informed consent and comply with follow-up plan
You will not qualify if you...
- Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; severe valvular stenosis or regurgitation; active endocarditis
- Symptomatic carotid stenosis, transient ischemic attack, or stroke within 30 days prior to randomization
- Untreated congenital heart disease
- Coronary revascularization (CABG or PCI) within 6 months prior to randomization or planned within 6 months
- Implanted or planned pacemakers within 6 months
- Planned atrial fibrillation ablation within 6 months
- Planned heart valve surgery within 6 months
- Listed for heart or heart-lung transplant or planned ventricular assist device implantation
- Other types of pulmonary hypertension (WHO Groups 1, 3, 4, 5)
- Use of pulmonary arterial hypertension targeted drugs within 1 month prior to randomization
- Planned surgery within 6 months
- Cardiac index below 1.5 L/min/m2
- Severe kidney insufficiency (eGFR below 30 mL/min/1.73m2)
- Severe liver insufficiency (Child-Pugh class C)
- Platelet count below 50 × 10^9/L
- Life expectancy under 1 year
- Systemic inflammation or diseases requiring long-term glucocorticoids or immunosuppressants
- Active infection needing antibiotics
- Body mass index over 40 kg/m2
- Pregnant or breastfeeding women or planning pregnancy within one year
- Participation in other clinical trials within 3 months prior to consent
- Any other condition deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Actively Recruiting
Research Team
M
Mark Gu
CONTACT
Y
Yanyan Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here