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
Qualifiers
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
Treatments tested in this trial
- Renal Denervation
- Sham
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Leipzig
Lead sponsor
ReCor Medical, Inc.
Collaborator
Source ClinicalTrials.gov