Heart failure hope? kidney nerve procedure tested in tiny study
NCT ID NCT04947670
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a procedure called renal denervation, which uses a catheter to calm overactive nerves in the kidneys, in people with chronic heart failure. The goal was to see if it is safe and feasible, and whether it could improve symptoms like walking distance and heart strain. Only 4 patients were enrolled before the study was terminated, so the results are very preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- renal denervation procedure
- What this could lead to
- If successful, this could point toward a new way to manage chronic heart failure by calming overactive nerves to the kidneys.
- What could go wrong
- This was a very small feasibility study (only 4 participants) that was terminated early, so results are limited. The procedure carries risks like any invasive vascular intervention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Saarland University Medical Center, Department for Internal Medicine III
Homburg/Saar, Saarland, 66421, Germany
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