Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Leipzig
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
≥1 main renal artery diameter <3.0 mm
main renal artery length < 20 mm
a single functioning kidney
presence of abnormal kidney tumors
Trial design
Design model
Parallel
Treatments tested in this trial
Renal Denervation
Procedure/SurgeryRenal denervation in patients with HFpEF and uncontrolled hypertension
Sham
Procedure/SurgerySham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: RDNExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
exercise pulmonary capillary wedge pressure (PCWP) at 20 W workload
To assess the hemodynamic effects of RDN in patients with HFpEF in comparison to sham-treatment
Time frame
6 months after randomizationSecondary outcomes
1
number of combination of death, increase in diuretic therapy, hospitalization for heart failure, worsening NYHA-class, change in pulmonary pressure parameters
number of combined endpoint in RDN and SHAM patients
Time frame
6, 12 and 24 months after RDN2
Change in mean Pulmonary artery (PA) pressure, estimated pulmonary artery diastolic pressure (ePAD) and PA pressure variability from pulmonary pressure sensor measurements
difference between RDN and sham
Time frame
6 months after randomization3
Change in mean PA pressure, ePAD and PA pressure variability from pulmonary pressure sensor measurements
Change in mean PA pressure, ePAD and PA pressure variability from pulmonary pressure sensor measurements, compared to baseline values
Time frame
6, 12 and 24 months after RDN4
Change in Systolic/Diastolic 24h blood pressure by ABPM and blood pressure variability
difference between RDN and sham
Time frame
6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leipzig
Lead sponsor
ReCor Medical, Inc.
Collaborator
Source ClinicalTrials.gov