Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction

Last updated: July 15, 2024
Sponsor: University of Leipzig
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Congestive Heart Failure

Heart Failure

Treatment

Renal Denervation

Sham

Clinical Study ID

NCT05030987
UNLOAD-HFpEF
CIV-20-10-034846
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. confirmed arterial hypertension (1-5 antihypertensive drugs without any dosagechange in the preceding 4 weeks) and average systolic BP between >125 and ≤170 mmHgand diastolic BP ≤110 mmHg in 24h ambulatory blood pressure measurement (ABPM)

  2. HFpEF (defined by clinical signs and/or symptoms of heart failure, objectivestructural cardiac abnormalities according to the ESC (European Society ofCardiology) criteria [1], elevated NT-proBNP ≥125 pg/mL and left-ventricularejection fraction ≥55%)

  3. NYHA-Class II or III

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

  5. Age 18-80 years

  6. Written informed consent

Exclusion

Exclusion Criteria:

  1. ≥1 main renal artery diameter <3.0 mm

  2. main renal artery length < 20 mm

  3. a single functioning kidney

  4. presence of abnormal kidney tumors

  5. renal artery aneurysm

  6. pre-existing renal stent or history of renal artery angioplasty

  7. fibromuscular disease of the renal arteries

  8. presence of renal artery stenosis of any origin ≥50%

  9. iliac/femoral artery stenosis precluding femoral access for RDN

  10. fertile women (within two years of their last menstruation) without appropriatecontraceptive measures (implanon, injections, oral contraceptives, intrauterinedevices, partner with vasectomy) while participating in the trial (participantsusing a hormone-based method have to be informed of possible effects of the trialdevice on contraception).

  11. participation in other interventional trials

  12. patients under legal supervision or guardianship

  13. suspected lack of compliance

  14. pregnant women

  15. Presence of intracardiac pacemakers or implantable cardioverter/defibrillators

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Renal Denervation
Phase:
Study Start date:
November 30, 2021
Estimated Completion Date:
March 31, 2026

Study Description

Heart failure is one of the most important diseases worldwide, with a 5-year mortality of up to 75% in symptomatic patients. While substantial progress has been made in the treatment of patients with reduced left ventricular ejection fraction (HFrEF), mortality for patients with heart failure and preserved ejection fraction (HFpEF) remains unchanged, despite a comparable prevalence and mortality of the disease as for heart failure with reduced ejection fraction.

HFpEF is a heterogeneous condition and has been a diagnostic and therapeutic challenge for clinicians and researchers over the past decades. While some rare cases of HFpEF can be attributed to specific diseases like amyloidosis, in most other patients common characteristics are increased ventricular filling pressures and ventricular and arterial stiffening as frequently caused by ageing, diabetes and arterial hypertension. Furthermore, increased sympathetic activity has been described as one pathogenic contributor to chronic heart failure and is associated with poor clinical prognosis. It also leads to a more pulsatile BP profile which can cause a mismatch in arterio-ventricular coupling.

The modulating effects on the sympathetic nervous system induced by renal denervation (RDN) should be beneficial in HFpEF, as they improve resting and exercise hemodynamics due to an improved ventriculoarterial coupling by reduced aortic stiffness and lower systemic blood pressure. In addition, RDN leads to optimized stroke volume and stroke work and might affect cardiac preload by improving blood distribution into the splanchnic compartment.

This study aims to explore the potential of RDN as a therapy for HFpEF in a single center pilot trial using a randomized, sham-controlled double-blind design.

Connect with a study center

  • Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin III

    Halle, Sachsen Anhalt 06120
    Germany

    Active - Recruiting

  • BG Klinikum Unfallkrankenhaus Berlin gGmbH

    Berlin, 13683
    Germany

    Active - Recruiting

  • Herzzentrum Leipzig, Universitätsklinik für Kardiologie

    Leipzig, 04289
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz, Zentrum für Kardiologie / Kardiologie 1

    Mainz, 55131
    Germany

    Active - Recruiting

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