Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction

NCT ID: NCT05030987

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2026-03-31

Brief 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.

Detailed 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.

Conditions

Heart Failure With Preserved Ejection Fraction; Hypertension, Renal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RDN

Renal Denervation

Group Type: EXPERIMENTAL

Renal Denervation

Intervention Type: PROCEDURE

Renal denervation in patients with HFpEF and uncontrolled hypertension

Sham

Sham Procedure

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: PROCEDURE

Sham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.

Interventions

Renal Denervation

Renal denervation in patients with HFpEF and uncontrolled hypertension

Intervention Type: PROCEDURE

Sham

Sham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.

Intervention Type: PROCEDURE

Other Intervention Names

Sham Procedure

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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%)

3. NYHA-Class II or III

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

5. Age 18-80 years

6. Written informed consent

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 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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReCor Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Karl Fengler

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Fengler, PhD

Role: STUDY_CHAIR

Herzzentrum Leipzig, Universitätsklinik für Kardiologie

Locations

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

Halle, Saxony-Anhalt, Germany

Site Status: RECRUITING

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, , Germany

Site Status: RECRUITING

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

Leipzig, , Germany

Site Status: NOT_YET_RECRUITING

Herzzentrum Leipzig, Universitätsklinik für Kardiologie

Leipzig, , Germany

Site Status: RECRUITING

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

Mainz, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Karl Fengler, PhD

Role: CONTACT

Karl.Fengler@medizin.uni-leipzig.de

49 341 ext. 8651426

Philipp Lurz, Prof. Dr.

Role: CONTACT

lurzphil@uni-mainz.de

49 6131 ext. 177251

Facility Contacts

Alexander Vogt, MD, PhD

Role: primary

alexander.vogt@uk-halle.de

+49 345 ext. 557 3134

Sebastian Winkler, MD, PhD

Role: primary

sebastian.winkler@ukb.de

+49 30 ext. 5681 3684

Leonhard Bruch, MD, PhD

Role: backup

leonhard.bruch@ukb.de

+49 30 ext. 5681 3601

Rolf Wachter, MD, Prof

Role: primary

rolf.wachter@medizin.uni-leipzig.de

+49 341 ext. 9720958

Karl Fengler, MD, PhD

Role: primary

karl.fengler@medizin.uni-leipzig.de

MD, PhD

Role: backup

Philipp Lurz, MD, Prof

Role: primary

lurzphil@uni-mainz.de

+49 6131 ext. 177251

Karl-Philipp Rommel, MD, PhD

Role: backup

rommelka@uni-mainz.de

Other Identifiers

CIV-20-10-034846

Identifier Type: OTHER

Identifier Source: secondary_id

UNLOAD-HFpEF

Identifier Type: -

Identifier Source: org_study_id