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

Primary Purpose

Heart Failure With Preserved Ejection Fraction, Renal Denervation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sham procedure and maintenance of heart failure medications
Renal denervation and maintenance of heart failure medications
Sponsored by
Xinjiang Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Renal denervation and maintenance of heart failure medications

    Sham intervention, maintenance of heart failure medications

    Arm Description

    Renal denervation in patients with HFpEF and uncontrolled hypertension

    Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.

    Outcomes

    Primary Outcome Measures

    Change from baseline E/E' at 12 months
    Echocardiography will be used to measure the E/E'

    Secondary Outcome Measures

    Number of participants with adverse events

    Full Information

    First Posted
    January 26, 2023
    Last Updated
    February 6, 2023
    Sponsor
    Xinjiang Medical University
    Collaborators
    First Affiliated Hospital of Xinjiang Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05715697
    Brief Title
    Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
    Acronym
    RDN-HFPEF
    Official Title
    The First Affiliated Hospital of Xinjiang Medical University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinjiang Medical University
    Collaborators
    First Affiliated Hospital of Xinjiang Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Preserved Ejection Fraction, Renal Denervation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Renal denervation and maintenance of heart failure medications
    Arm Type
    Experimental
    Arm Description
    Renal denervation in patients with HFpEF and uncontrolled hypertension
    Arm Title
    Sham intervention, maintenance of heart failure medications
    Arm Type
    Sham Comparator
    Arm Description
    Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham procedure and maintenance of heart failure medications
    Intervention Description
    Sham intervention, maintenance of heart failure medications
    Intervention Type
    Procedure
    Intervention Name(s)
    Renal denervation and maintenance of heart failure medications
    Intervention Description
    Renal denervation and maintenance of heart failure medications
    Primary Outcome Measure Information:
    Title
    Change from baseline E/E' at 12 months
    Description
    Echocardiography will be used to measure the E/E'
    Time Frame
    12 months after treatment
    Secondary Outcome Measure Information:
    Title
    Number of participants with adverse events
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiang Xie
    Phone
    +869914366892
    Email
    xiangxie999@sina.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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