Actively Recruiting
Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
Led by University of Leipzig · Updated on 2024-07-17
68
Participants Needed
5
Research Sites
226 weeks
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
R
ReCor Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed arterial hypertension treated with 1-5 antihypertensive drugs without dosage change in the past 4 weeks
- Average systolic blood pressure between >125 and 4170 mmHg and diastolic blood pressure 4110 mmHg in 24-hour ambulatory measurement
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) by clinical signs, structural heart abnormalities per ESC criteria, NT-proBNP 4125 pg/mL, and left ventricular ejection fraction 455%
- New York Heart Association (NYHA) class II or III
- Elevated cardiac filling pressures confirmed by catheterization (LVEDP 416 mmHg or PCWP 415 mmHg at rest or 425 mmHg during exercise)
- Age between 18 and 80 years
- Written informed consent provided
You will not qualify if you...
- Main renal artery diameter less than 3.0 mm
- Main renal artery length less than 20 mm
- Having only one functioning kidney
- Presence of abnormal kidney tumors
- Renal artery aneurysm
- Previous renal stent or history of renal artery angioplasty
- Fibromuscular disease of the renal arteries
- Renal artery stenosis of 50% or greater
- Iliac or femoral artery stenosis preventing femoral access for renal denervation
- Fertile women within two years of last menstruation without reliable contraception
- Participation in other interventional clinical trials
- Under legal supervision or guardianship
- Suspected lack of compliance
- Pregnant women
- Presence of intracardiac pacemakers or implantable cardioverter/defibrillators
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin III
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
2
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, Germany, 13683
Actively Recruiting
3
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie
Leipzig, Germany, 04103
Not Yet Recruiting
4
Herzzentrum Leipzig, Universitätsklinik für Kardiologie
Leipzig, Germany, 04289
Actively Recruiting
5
Universitätsmedizin der Johannes Gutenberg Universität Mainz, Zentrum für Kardiologie / Kardiologie 1
Mainz, Germany, 55131
Actively Recruiting
Research Team
K
Karl Fengler, PhD
CONTACT
P
Philipp Lurz, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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