Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

• 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%)

• NYHA-Class II or III

• Confirmation of an elevated cardiac filling pressures (either LVEDP \>= 16 mmHg or PCWP \>= 15 mmHg at rest or \>=25 mmHg during exercise) by catheterization

• Age 18-80 years

• Written informed consent

Locations
Other Locations
Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH
RECRUITING
Berlin
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin III
RECRUITING
Halle
Herzzentrum Leipzig, Universitätsklinik für Kardiologie
RECRUITING
Leipzig
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie
NOT_YET_RECRUITING
Leipzig
Universitätsmedizin der Johannes Gutenberg Universität Mainz, Zentrum für Kardiologie / Kardiologie 1
RECRUITING
Mainz
Contact Information
Primary
Karl Fengler, PhD
Karl.Fengler@medizin.uni-leipzig.de
49 341
Backup
Philipp Lurz, Prof. Dr.
lurzphil@uni-mainz.de
49 6131
Time Frame
Start Date: 2021-11-30
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 68
Treatments
Experimental: RDN
Renal Denervation
Sham_comparator: Sham
Sham Procedure
Sponsors
Leads: University of Leipzig
Collaborators: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov