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

Official title

The First Affiliated Hospital of Xinjiang Medical University

Overview

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.

Interventions

• Procedure Sham procedure and maintenance of heart failure medications
  Sham intervention, maintenance of heart failure medications
• Procedure Renal denervation and maintenance of heart failure medications
  Renal denervation and maintenance of heart failure medications

Primary outcome measures

• Change from baseline E/E' at 12 months [Time frame: 12 months after treatment]

Secondary outcome measures (1)

• Number of participants with adverse events [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• signs or symptoms of heart failure;
• normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
• evidence of diastolic LV dysfunction.
• 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).
• 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

• Known secondary cause of hypertension
• Anatomy not eligible for renal denervation
• Systolic heart failure (LVEF < 50%)
• Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
• 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).
• Individual is pregnant, nursing or planning to be pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Identifiers

NCT: NCT05715697 · 20230126-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗