Heart Failure With Preserved Ejection FractionRDN-HFPEFNCT05715697
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
A study testing Renal denervation and maintenance of heart failure medications in people with Heart Failure With Preserved Ejection Fraction and Renal Denervation, run by Xinjiang Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Renal Denervation
- What is being tested?
- Renal denervation and maintenance of heart failure medications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Hai-tao Yang, +869914366892, yht5656@163.com
xiang Xie, +869914366892, xiangxie999@sina.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Sham procedure and maintenance of heart failure medications, Renal denervation and maintenance of heart failure medications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham procedure and maintenance of heart failure medicationsProcedure or surgery
Sham intervention, maintenance of heart failure medications
Renal denervation and maintenance of heart failure medicationsProcedure or surgery
Renal denervation and maintenance of heart failure medications
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation and maintenance of heart failure medications | Experimental | Renal denervation in patients with HFpEF and uncontrolled hypertension Receives: Procedure: Renal denervation and maintenance of heart failure medications |
| Sham intervention, maintenance of heart failure medications | Sham comparator | Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation. Receives: Procedure: Sham procedure and maintenance of heart failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline E/E' at 12 months
Echocardiography will be used to measure the E/E'
Measured: 12 months after treatment
Secondary outcomes (1)
Number of participants with adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Xiang Xie, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715697
- Sponsor's protocol ID
- 20230126-03
- Acronym
- RDN-HFPEF
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Xinjiang Medical University
- ClinicalTrials.gov ID
- NCT05715697
- Acronym / sponsor ID
- RDN-HFPEF / 20230126-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation and maintenance of heart failure medications | Experimental | Procedure: Renal denervation and maintenance of heart failure medicationsRenal denervation in patients with HFpEF and uncontrolled hypertension |
| Sham intervention, maintenance of heart failure medications | Sham comparator | Procedure: Sham procedure and maintenance of heart failure medicationsSham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham procedure and maintenance of heart failure medicationsSham intervention, maintenance of heart failure medications | Procedure or surgery | Sham intervention, maintenance of heart failure medications |
| Renal denervation and maintenance of heart failure medicationsRenal denervation and maintenance of heart failure medications | Procedure or surgery | Renal denervation and maintenance of heart failure medications |
Primary outcome
Change from baseline E/E' at 12 months
Time frame: 12 months after treatment
Echocardiography will be used to measure the E/E'
1 secondary outcome
Number of participants with adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation and maintenance of heart failure medications in people with Heart Failure With Preserved Ejection Fraction and Renal Denervation, run by Xinjiang Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Xie (+869914366892, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline E/E' at 12 months (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.