NCT05030987

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

3.1 years

First QC Date

August 30, 2021

Last Update Submit

July 15, 2024

Conditions

Heart Failure With Preserved Ejection FractionHypertension, Renal

Keywords

Renal DenervationHypertensionHeart Failure with Preserved Ejection Fraction

Outcome Measures

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

    6 months after randomization

Secondary Outcomes (24)

  • number of combination of death, increase in diuretic therapy, hospitalization for heart failure, worsening NYHA-class, change in pulmonary pressure parameters

    6, 12 and 24 months after RDN

  • Change in mean Pulmonary artery (PA) pressure, estimated pulmonary artery diastolic pressure (ePAD) and PA pressure variability from pulmonary pressure sensor measurements

    6 months after randomization

  • Change in mean PA pressure, ePAD and PA pressure variability from pulmonary pressure sensor measurements

    6, 12 and 24 months after RDN

  • Change in Systolic/Diastolic 24h blood pressure by ABPM and blood pressure variability

    6 months after randomization

  • Change in Systolic/Diastolic 24h blood pressure by ABPM and blood pressure variability

    6, 12 and 24 months after RDN

  • +19 more secondary outcomes

Study Arms (2)

RDN

EXPERIMENTAL

Renal Denervation

Procedure: Renal Denervation

Sham

SHAM COMPARATOR

Sham Procedure

Procedure: Sham

Interventions

Renal DenervationPROCEDURE

Renal denervation in patients with HFpEF and uncontrolled hypertension

RDN
ShamPROCEDURE

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

Also known as: Sham Procedure
Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ≥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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, 13683, Germany

RECRUITING

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

Leipzig, 04103, Germany

NOT YET RECRUITING

Herzzentrum Leipzig, Universitätsklinik für Kardiologie

Leipzig, 04289, Germany

RECRUITING

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

Mainz, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension, RenalHypertension

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Karl Fengler, PhD

    Herzzentrum Leipzig, Universitätsklinik für Kardiologie

    STUDY CHAIR

Central Study Contacts

Karl Fengler, PhD

CONTACT

49 341Karl.Fengler@medizin.uni-leipzig.de

Philipp Lurz, Prof. Dr.

CONTACT

49 6131lurzphil@uni-mainz.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 1, 2021

Study Start

November 30, 2021

Primary Completion

December 31, 2024

Study Completion

March 31, 2026

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis. Summary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the trial protocol in full will be made publically available as well as the statistical analysis plan.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after publication of the major results

Locations

DE(5)