A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure

Launched by UNIVERSITÄT DES SAARLANDES · Jun 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called renal denervation, which aims to help patients with chronic heart failure (CHF) by reducing the activity of certain nerves in the kidneys that may worsen their condition. The trial will involve a larger number of patients to see if this treatment is safe and can improve symptoms of heart failure, which is a serious condition where the heart struggles to pump blood effectively.

To be eligible for this study, participants must be adults aged 18 to 80 who have been diagnosed with chronic heart failure for at least three months and have specific symptoms and test results indicating their heart is not functioning well. They should also be stable on heart failure medications for at least four weeks before joining the trial. Participants can expect to receive either the renal denervation treatment or a placebo (a sham treatment that does not have any active ingredients) in a controlled setting. This study is important because it will help researchers understand how renal denervation can affect heart failure and potentially lead to better treatments in the future.

Gender

ALL

Eligibility 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