Exploring renal denervation for heart failure with preserved ejection fraction

The First Affiliated Hospital of Xinjiang Medical University

This study is testing if a new treatment called renal denervation can help people with heart failure and preserved ejection fraction feel better when combined with their regular heart medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Xinjiang Medical University (other)
• Locations: 1 site (Ürümqi, Xinjiang)
• Trial ID: NCT05715697 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of renal denervation (RDN) as a treatment for patients suffering from heart failure with preserved ejection fraction (HFpEF). It is designed as a prospective, multicenter, randomized, blinded, sham-controlled trial, aiming to provide insights into a condition that currently lacks effective therapeutic options. The study will compare the outcomes of patients receiving RDN alongside standard heart failure medications to those undergoing a sham procedure with the same medication regimen. The goal is to determine if RDN can improve symptoms and outcomes in this high-risk patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with signs or symptoms of heart failure, preserved left ventricular function, and controlled hypertension.

Not a fit: Patients with systolic heart failure, secondary hypertension, or significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for patients with HFpEF, potentially improving their quality of life and survival rates.

How similar studies have performed: While the approach of renal denervation has been explored in other contexts, its application for HFpEF is relatively novel and has not been extensively tested.

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.

Where this trial is running

Ürümqi, Xinjiang

• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (RECRUITING)

Study contacts

• Study coordinator: Xiang Xie

Conditions: Heart Failure With Preserved Ejection Fraction, Renal Denervation