Phase
Condition
Chest Pain
Heart Disease
Scleroderma
Treatment
Guideline-directed medical therapy (GDMT) for heart failure
Pulmonary arterial denervation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18, ≤75 years old;
Diagnosed with chronic heart failure for at least 3 months, and have received theGDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failurefor at least 1 month;
Clinically stable defined by
No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg and resting heart rate (HR) ≥50 and <100 bpm (<110 bpm for atrial fibrillation) on the day of the procedure
New York Heart Association (NYHA) class II-IVa;
6MWD ≥ 100 m and < 450 m;
NT-proBNP > 125 pg/mL (BNP > 35 pg/mL);
Hemodynamic indicators (RHC) :
Mean pulmonary arterial pressure (mPAP) > 20 mmHg
Pulmonary capillary wedge pressure (PCWP) >15 mmHg
Understand and be willing to sign informed consent, and be willing to follow thefollow-up plan required by the protocol.
Exclusion
Exclusion Criteria:
Any of the following:
Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction orsystolic anterior motion; pericardial disease; infiltrative or inflammatorymyocardial disease; valvular stenosis of any of the 4 valves, or severeregurgitation of aortic and pulmonary valves, or active endocarditis; or
Symptomatic carotid stenosis, or transient ischemic attack (TIA) or strokewithin 30 days prior to randomization; or
Untreated congenital heart disease; or
Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior torandomization; or anticipated to undergo coronary revascularization (CABG orPCI) within 6 months; or
Artificial pacemakers, including single-chamber, dual-chamber and three-chamberpacemakers, have been implanted or are anticipated to be implanted within 6months; 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)
Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month priorto randomization;
Anticipated to undergo any surgery within 6 months;
The cardiac index (CI) of RHC < 1.5L/min/m²;
Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula);
Severe liver insufficiency (Child-Pugh classification C);
Platelet count < 50 × 10^9/L;
Life expectancy <1 year;
Systemic inflammation or other disease requiring long-term use of glucocorticoids orimmunosuppressants;
Active infection requiring oral or intravenous antibiotics;
Body mass index (BMI) >40 kg/m²;
Pregnant or lactating women, or plan to pregnant in one year;
Participated in other clinical trials within 3 months prior to signing the informedconsent;
Any other circumstances that investigators deem inappropriate to participate in thistrial.
Study Design
Study Description
Connect with a study center
General Hospital of Northern Theater Command
Shenyang, Liaoning
ChinaActive - Recruiting
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