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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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥18, ≤85 years;
PH must be confirmed by RHC, defined as:
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;
Clinically stable HF for at least 1 month, defined as:
NYHA class II-IVa;
6MWD ≥ 100 m and ≤ 450 m;
NT-proBNP >125pg/mL (or BNP > 35pg/mL);
Understand and be willing to sign informed consent and be strictly willing to follow the protocol.
Exclusion criteria
Any of the following:
Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
Anticipated to undergo any surgery within the next 6 months;
Cardiac index (CI) measured by RHC < 1.5L/min/m2;
Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula);
Severe liver insufficiency (Child-Pugh classification B-C);
Platelet count < 50 × 109/L;
Life expectancy < 1 year;
Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
Active infection requiring oral or intravenous antibiotics;
Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;
Body mass index (BMI) > 40 kg/m²;
Pregnant or lactating women, or planning to be pregnant within one year;
Participation in other clinical trials within 3 months prior to signing the informed consent;
Any other circumstances that investigators deemed inappropriate to participate in this trial.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Ruben Ramos, Doctor
Data sourced from clinicaltrials.gov
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