Renal denervation for patients with chronic heart failure
A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure
This study is testing if a new procedure that targets nerves in the kidneys can help people with chronic heart failure feel better and improve their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universität des Saarlandes Academic / other |
| Locations | 1 site (Homburg/Saar, Saarland) |
| Trial ID | NCT04947670 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of renal denervation in patients suffering from chronic heart failure. It aims to manipulate the sympathetic activation associated with heart failure by using the Paradise Catheter System to denervate renal sympathetic nerves. The trial will involve a multicenter, randomized, and sham-controlled design, with both inter-individual and intra-individual controls to assess outcomes. The study builds on preliminary pilot results that suggest potential improvements in symptoms without significant safety concerns.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic heart failure for at least three months, with specific functional and clinical criteria.
Not a fit: Patients with stable chronic heart failure who do not meet the inclusion criteria or have contraindications to renal denervation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of chronic heart failure symptoms and better patient outcomes.
How similar studies have performed: Previous pilot studies and EU randomized controlled studies have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with CHF diagnosed for at least 3 months prior to consent * 6-min walk distance ≤350 m * NYHA Class II-III symptoms of CHF * Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction \<45% * eGFR calculated (CKD-EPI) \>30 ml/min/1.73 m2 * NT-pro-BNP \>450 pg/ml, \>900 pg/ml for patients with atrial fibrillation * Optimal medical drug therapy according to current guidelines for CHF management. This medication may include loop diuretics, ACEi/ARBs, ARNI, SGLT-2 inhibitors, aldosterone antagonists, and beta-blockers, unless intolerance to any of the above is documented. Treatment for HF must be stable (including drug and dose) for 4 weeks prior to randomization, except diuretics (2 weeks stable) * Appropriate use of medical devices such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international guidelines, and if a device is required, it must have been implanted for at least 3 months prior to consent for CRT and 1 month prior to consent for ICD * Age ≥18 years and ≤80 years Exclusion Criteria: * Renal arterial anatomy that is ineligible for treatment * Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 12 weeks prior to consent * Office systolic BP at screening \<90 mmHg * Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve * Hypertrophic obstructive cardiomyopathy * Major surgery in the previous 12 weeks prior to consent * Hospitalization for decompensated CHF in the \<30 days prior to consent * Parenteral therapy for the treatment of CHF * Respiratory support (excluding sleep apnea therapy) * Left ventricular assist or planned heart transplantation * Patient is pregnant, nursing, or planning to be pregnant * Ineligibility to consent * Primary pulmonary hypertension (systolic PAP \>70 mmHg) * BMI ≥40 kg/m² * Any condition that would contraindicate the assessment of 6-min walk distance. * Patient has type I diabetes mellitus
Where this trial is running
Homburg/Saar, Saarland
- Saarland University Medical Center, Department for Internal Medicine III — Homburg/Saar, Saarland, Germany (Recruiting)
Study contacts
- Principal investigator: Felix Mahfoud, MD — Saarland University Medical Center
- Study coordinator: Felix Mahfoud, MD
- Email: Felix.Mahfoud@uks.eu
- Phone: +49-6841-16-15911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.