Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial
University of Leipzig
68 participants
Nov 30, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria15
- ≥1 main renal artery diameter \<3.0 mm
- main renal artery length \< 20 mm
- a single functioning kidney
- presence of abnormal kidney tumors
- renal artery aneurysm
- pre-existing renal stent or history of renal artery angioplasty
- fibromuscular disease of the renal arteries
- presence of renal artery stenosis of any origin ≥50%
- iliac/femoral artery stenosis precluding femoral access for RDN
- 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).
- participation in other interventional trials
- patients under legal supervision or guardianship
- suspected lack of compliance
- pregnant women
- Presence of intracardiac pacemakers or implantable cardioverter/defibrillators
Interventions
Renal denervation in patients with HFpEF and uncontrolled hypertension
Sham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05030987