Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction (RDN-HFPEF)

January 30, 2024 updated by: Xiang Xie, Xinjiang Medical University

The First Affiliated Hospital of Xinjiang Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal denervation and maintenance of heart failure medications
Renal denervation in patients with HFpEF and uncontrolled hypertension
Procedure: Renal denervation and maintenance of heart failure medications
Renal denervation and maintenance of heart failure medications
Sham Comparator: Sham intervention, maintenance of heart failure medications
Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.
Procedure: Sham procedure and maintenance of heart failure medications
Sham intervention, maintenance of heart failure medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline E/E' at 12 months
Time Frame: 12 months after treatment
Echocardiography will be used to measure the E/E'
12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinjiang Medical University

Collaborators

First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230126-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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