NCT05030987 Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT05030987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leipzig |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2021-11-30 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2021-11-30 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of renal denervation as a treatment option for heart failure with preserved ejection fraction.
Eligibility 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
Contact & Investigator
Karl Fengler, PhD
STUDY CHAIR
Herzzentrum Leipzig - Universitätsklinik für Kardiologie
Frequently Asked Questions
Who can join the NCT05030987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05030987 currently recruiting?
Yes, NCT05030987 is actively recruiting participants. Contact the research team at Karl.Fengler@medizin.uni-leipzig.de for enrollment information.
Where is the NCT05030987 trial being conducted?
This trial is being conducted at Halle, Germany, Berlin, Germany, Leipzig, Germany, Leipzig, Germany and 1 additional location.
Who is sponsoring the NCT05030987 clinical trial?
NCT05030987 is sponsored by University of Leipzig. The principal investigator is Karl Fengler, PhD at Herzzentrum Leipzig - Universitätsklinik für Kardiologie. The trial plans to enroll 68 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.