Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pu… (NCT05996562) | Clinical Trial Compass
CompletedNot Applicable
Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure（PADN-CpcPH-PILOT）
Portugal30 participantsStarted 2024-06-28
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age ≥18, ≤85 years;
✓. PH must be confirmed by RHC, defined as:
✓. Mean pulmonary arterial pressure (mPAP) \>20mmHg, and;
✓. 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:
✓. No need of intravenous diuretics, inotropes or vasodilators, and
Exclusion criteria
✕. Any of the following:
✕. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction 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