Heart Failure With Preserved Ejection Fraction, Renal Denervation
Conditions
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.
Interventions
PROCEDURESham procedure and maintenance of heart failure medications
Sham intervention, maintenance of heart failure medications
PROCEDURERenal denervation and maintenance of heart failure medications
Renal denervation and maintenance of heart failure medications
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Xinjiang Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline E/E' at 12 months | 12 months after treatment | Echocardiography will be used to measure the E/E' |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 1 year |
Countries
China
Contacts
Primary ContactXiang Xie
Outcome results
None listed