Phase
Condition
Heart Failure
Circulation Disorders
Heart Disease
Treatment
Pulmonary Artery Denervation
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18, ≤85 years;
PH must be confirmed by RHC, defined as:
Mean pulmonary arterial pressure (mPAP) > 20mmHg, and;
Pulmonary capillary wedge pressure (PCWP) >15mmHg.
Chronic heart failure has been diagnosed at least 3 months before screening and havebeen treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure forat least 1 month;
Clinically stable HF for at least 1 month, defined as:
No need of intravenous diuretics, inotropes or vasodilators, and
Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and
Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence ofatrial fibrillation) on the day of the procedure.
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 followthe protocol.
Exclusion
Exclusion Criteria:
Any of the following:
Hypertrophic cardiomyopathy with left ventricular (LV) outflow tractobstruction and/or mitral valvular systolic anterior motion (SAM); or
Pericardial disease; or
Infiltrative or inflammatory myocardial disease; or
Valvular heart disease with stenosis or with severe regurgitation; or
Active endocarditis; or
Symptomatic carotid stenosis, or TIA or stroke within 30 days prior torandomization; or
Congenital heart disease; or
Having received any revascularization, including coronary artery bypassgrafting (CABG) or percutaneous coronary intervention (PCI) within 6 monthsprior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
Artificial pacemakers, including single-chamber, dual-chamber and three-chamberpacemakers, have been implanted less than 6 months or are anticipated to beimplanted within 6 months; or
Anticipated to undergo ablation of atrial fibrillation within 6 months; or
Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty)within 6 months; or
Listing for heart/heart-lung transplantation or anticipated to implant aventricular assist device (VAD)
Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month priorto 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 orimmunosuppressants;
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 informedconsent;
Any other circumstances that investigators deemed inappropriate to participate inthis trial.
Study Design
Connect with a study center
Hospital de Santa Marta
Lisbon,
PortugalActive - Recruiting
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