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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— RDN-HFPEF  

Official title:

The First Affiliated Hospital of Xinjiang Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715697
• Other study ID #: 20230126-03
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Xinjiang Medical University
• Contact: Xiang Xie
• Phone: +869914366892
• Email: xiangxie999[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Renal Denervation

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang

Sponsors (2)

Lead Sponsor	Collaborator
Xinjiang Medical University	First Affiliated Hospital of Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline E/E' at 12 months	Echocardiography will be used to measure the E/E'	12 months after treatment
Secondary	Number of participants with adverse events		1 year