Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-01

Brief Summary

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This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

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Detailed Description

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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. 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 RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Conditions

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Heart Failure With Preserved Ejection Fraction Renal Denervation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Renal denervation and maintenance of heart failure medications

Renal denervation in patients with HFpEF and uncontrolled hypertension

Group Type EXPERIMENTAL

Renal denervation and maintenance of heart failure medications

Intervention Type PROCEDURE

Renal denervation and maintenance of heart failure medications

Sham intervention, maintenance of heart failure medications

Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.

Group Type SHAM_COMPARATOR

Sham procedure and maintenance of heart failure medications

Intervention Type PROCEDURE

Sham intervention, maintenance of heart failure medications

Interventions

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Sham procedure and maintenance of heart failure medications

Sham intervention, maintenance of heart failure medications

Intervention Type PROCEDURE

Renal denervation and maintenance of heart failure medications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. signs or symptoms of heart failure;
2. normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
3. evidence of diastolic LV dysfunction.
4. Individual should fulfill the diagnostic WHO criteria for hypertension: SBP \> 140 mmHg and/or DBP \> 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (\< 140/90mmHg by 24 hour ambulatory BP measurement).
5. Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.

Exclusion Criteria

1. Known secondary cause of hypertension
2. Anatomy not eligible for renal denervation
3. Systolic heart failure (LVEF \< 50%)
4. Individual has an estimated glomerular filtration rate (eGFR) of \< 30mL/min/1.73m2, using the MDRD calculation.
5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
6. Individual is pregnant, nursing or planning to be pregnant.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No