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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT05030987
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- confirmed arterial hypertension (1-5 antihypertensive drugs without any dosage change in the preceding 4 weeks) and average systolic BP between \>125...
- HFpEF (defined by clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalities according to the ESC (European Society...
- 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...
- Age 18-80 years
You likely can't join 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
See the full eligibility criteria
- 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...
- 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...
- 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
- ≥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...
- participation in other treatment trials
- patients under legal supervision or guardianship
- suspected lack of compliance
- pregnant women
- Presence of intracardiac pacemakers or implantable cardioverter/defibrillators
The study team makes the final eligibility decision.
Where it's taking place
- Halle, Saxony-Anhalt, Germany
- Berlin, Germany
- Leipzig, Germany
- Mainz, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halle, Saxony-Anhalt, Germany; Berlin, Germany; Leipzig, Germany; Mainz, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.