Using ultrasound to treat pulmonary hypertension in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the Gradient Denervation System, which utilizes ultrasound ablation to reduce sympathetic nervous activity in the pulmonary artery. The goal is to improve the quality of life for heart failure patients suffering from Group 2 pulmonary hypertension. Participants will undergo a procedure where a catheter is used to deliver targeted ultrasound energy to specific locations in the pulmonary artery. The study aims to assess changes in pulmonary artery pressure and overall patient well-being following the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion Criteria:

* Unwilling to provide informed consent or complete follow-up assessments
* Life expectancy of \< 2 years
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Unable to tolerate right heart catheterization
* Severe aortic, mitral or pulmonary valve regurgitation
* Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
* Systemic infection or localized infection/rash at planned access site at time of procedure
* CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months

Where it's running

• Hospital Universitari Germans Trias i Pujol
  Badalona, Spain Recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Clínico Universitario de Valencia
  Valencia, Spain Recruiting

Study contacts

• Study coordinator: Julie Etheridge
• Email: clinical@gradientdenervation.com
• Phone: +49 16094434355

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Levosimendan to see if it helps the heart after PEA in CTEPH

  This small randomized trial tests whether giving levosimendan around surgery helps reduce pulmonary artery pressure and support right heart function after pulmonary endarterectomy for CTEPH.

  Recruiting Meshalkin Research Institute of Pathology of Circulation · Novosibirsk · NCT07914933

• Early treatment with inhaled treprostinil for exercise-induced pulmonary hypertension in ILD or CTD

  This study tests whether inhaled treprostinil added to standard care can improve exercise-related lung blood flow and function in adults with ILD or CTD who develop pulmonary hypertension during exercise.

  Recruiting at 2 sites Early Phase 1 Valley Health System · Paramus, New Jersey and 1 other locations · NCT07837830

• Brazilian Portuguese version of EmPHasis-10 for pulmonary hypertension

  This study tests a Brazilian Portuguese version of the EmPHasis-10 questionnaire to see if it reliably measures quality of life in adults with pulmonary hypertension in Porto Alegre, Brazil.

  Recruiting Hospital de Clinicas de Porto Alegre · Porto Alegre · NCT07822997

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Pulmonary Artery Denervation for Pulmonary Hypertension After M-TEER

  This study tests whether PADN can help people with pulmonary hypertension after M-TEER compared with standard medical therapy.

  Recruiting Early Phase 1 Xiamen Cardiovascular Hospital, Xiamen University · Xiamen, Fujian · NCT07662655

• Risk Factor Assessment for Acute Pulmonary Hypertension Crisis

  This study tests how to identify people with pulmonary hypertension who are at risk of a sudden, life-threatening crisis.

  Recruiting at 4 sites Peking Union Medical College Hospital · Guangzhou, Guangdong and 3 other locations · NCT07653958

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.