- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05715697
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
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
- Name: xiang Xie
- Phone Number: +869914366892
- Email: xiangxie999@sina.com
Study Locations
-
-
Xinjiang
-
Urumqi, Xinjiang, China, 830000
- Recruiting
- The first affiliated hospital of Xinjiang medical university
-
Contact:
- xiang Xie
- Phone Number: +869914366892
- Email: xiangxie999@sina.com
-
Contact:
- Hai-tao Yang
- Phone Number: +869914366892
- Email: yht5656@163.com
-
-
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:
- 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.
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
|
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.
|
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
Collaborators
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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Clinical Trials on Renal denervation and maintenance of heart failure medications
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University College, LondonUniversity College London Hospitals; Barts & The London NHS Trust; British Heart...RecruitingHeart Failure | HER2-positive Breast Cancer | Cardiotoxicity | Cancer, Therapy-RelatedUnited Kingdom
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Pulnovo Medical (Wuxi) Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsRecruitingCardiovascular Diseases | Vascular Diseases | Heart Failure | Hypertension | Pulmonary Hypertension | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
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Paracor Medical, IncTerminatedHeart FailureUnited States, Canada
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Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Heart Failure, CongestiveUnited States
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Shanghai AngioCare MedicalTerminatedResistant Hypertension | Renal Denervation | Standard MedicationChina
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