Using renal denervation to treat heart failure with preserved ejection fraction
Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial
This study is testing if a procedure called renal denervation can help people with heart failure and preserved ejection fraction feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 5 sites (Halle, Saxony-Anhalt and 4 other locations) |
| Trial ID | NCT05030987 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of renal denervation as a potential treatment for heart failure with preserved ejection fraction (HFpEF), a condition with high mortality and limited treatment options. It aims to assess the effects of renal denervation on sympathetic nervous system modulation, which may improve hemodynamics and reduce blood pressure in patients with HFpEF. Participants will be monitored for changes in cardiac function and overall health outcomes. The study includes a sham control group to compare the effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with confirmed hypertension and clinical signs of heart failure with preserved ejection fraction.
Not a fit: Patients with significant renal artery abnormalities or those with a single functioning kidney may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from heart failure with preserved ejection fraction.
How similar studies have performed: While renal denervation has shown promise in other cardiovascular conditions, its application for heart failure with preserved ejection fraction is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. confirmed arterial hypertension (1-5 antihypertensive drugs without any dosage change in the preceding 4 weeks) and average systolic BP between \>125 and ≤170 mmHg and diastolic BP ≤110 mmHg in 24h ambulatory blood pressure measurement (ABPM) 2. HFpEF (defined by clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalities according to the ESC (European Society of Cardiology) criteria \[1\], elevated NT-proBNP ≥125 pg/mL and left-ventricular ejection fraction ≥55%) 3. NYHA-Class II or III 4. Confirmation of an elevated cardiac filling pressures (either LVEDP \>= 16 mmHg or PCWP \>= 15 mmHg at rest or \>=25 mmHg during exercise) by catheterization 5. Age 18-80 years 6. Written informed consent Exclusion Criteria: 1. ≥1 main renal artery diameter \<3.0 mm 2. main renal artery length \< 20 mm 3. a single functioning kidney 4. presence of abnormal kidney tumors 5. renal artery aneurysm 6. pre-existing renal stent or history of renal artery angioplasty 7. fibromuscular disease of the renal arteries 8. presence of renal artery stenosis of any origin ≥50% 9. iliac/femoral artery stenosis precluding femoral access for RDN 10. fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial device on contraception). 11. participation in other interventional trials 12. patients under legal supervision or guardianship 13. suspected lack of compliance 14. pregnant women 15. Presence of intracardiac pacemakers or implantable cardioverter/defibrillators
Where this trial is running
Halle, Saxony-Anhalt and 4 other locations
- Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin III — Halle, Saxony-Anhalt, Germany (Recruiting)
- BG Klinikum Unfallkrankenhaus Berlin gGmbH — Berlin, Germany (Recruiting)
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie — Leipzig, Germany (Not_yet_recruiting)
- Herzzentrum Leipzig, Universitätsklinik für Kardiologie — Leipzig, Germany (Recruiting)
- Universitätsmedizin der Johannes Gutenberg Universität Mainz, Zentrum für Kardiologie / Kardiologie 1 — Mainz, Germany (Recruiting)
Study contacts
- Study coordinator: Karl Fengler, PhD
- Email: Karl.Fengler@medizin.uni-leipzig.de
- Phone: 49 341
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.