Clinical trial NCT05715697: Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Official title: The First Affiliated Hospital of Xinjiang Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Renal Denervation
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2023-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline E/E' at 12 months
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: