RecruitingNot ApplicableNCT05030987

Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction

Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial


Sponsor

University of Leipzig

Enrollment

68 participants

Start Date

Nov 30, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether renal denervation — a catheter-based procedure that uses radiofrequency energy to reduce overactive nerve signals in the kidney — can improve symptoms in patients who have heart failure with preserved ejection fraction (HFpEF) combined with high blood pressure. HFpEF means the heart squeezes normally but is too stiff to fill properly. **You may be eligible if...** - You are 18–80 years old - You have confirmed high blood pressure managed with medications - You have HFpEF with symptoms (NYHA Class II or III — meaning some to significant limitations with activity) - Your heart fills under elevated pressure (confirmed by catheterization) - Your heart pumps at 55% or more efficiency - Your NT-proBNP (heart stress marker) is elevated **You may NOT be eligible if...** - Your kidney arteries are too small or have disease (stenosis, aneurysm, prior stent) - You have a single functioning kidney - You have severe valve disease or other structural heart conditions - You are pregnant or of childbearing potential without adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERenal Denervation

Renal denervation in patients with HFpEF and uncontrolled hypertension

PROCEDURESham

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


Locations(5)

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

Halle, Saxony-Anhalt, Germany

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

Leipzig, Germany

Herzzentrum Leipzig, Universitätsklinik für Kardiologie

Leipzig, Germany

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

Mainz, Germany

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NCT05030987


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