HypertensionNCT02243514
Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases
An observational study of Hypertension and Heart Failure, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an important part in the autonomic nervous system regulation, especially in cardiovascular system, the modulation of the renal nerves used as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Heart Failure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to May 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients who are going to take a vascular interventional examination.
Who may be able to join
- Resistant hypertension group
- blood pressure remains above goal in spite of the concurrent use of three or more anti-hypertensive agents(including a diuretic) at adequate doses.
- agrees to have the study procedure(s) performed and additional procedures and evaluations
- Essential hypertension group
- systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, or current use of anti-hypertensive medication with a normal blood pressure or mean ambulatory blood pressure during the 24-hour≥130/80 mmHg.
- not resistant to pharmacotherapy.
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- agrees to have the study procedure(s) performed and additional procedures and evaluations
- Chronic heart failure group
- New York Heart Association class II-III symptoms, or American College of Cardiology(ACC) / American Heart Association(AHA) heart failure classification B-C class of chronic heart failure.
- currently or prior have the signs of heart failure, such as elevated jugular venous pressure, peripheral edema, pulmonary crepitations, ect.
- Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction < 40%.
- agrees to have the study procedure(s) performed and additional procedures and evaluations
- Control group
- no history of arterial hypertension, heart failure and diabetes
- going to take a vascular interventional examination during hospitalization
- agrees to have the study procedure(s) performed and additional procedures and evaluations
- All patients have full capacity for civil conduct and agree to sign the Medical Informed Consent.
Who cannot join
- hemodynamically or anatomically significant renal artery stenosis.
- renal artery variation.
- renal artery diameter < 4 mm, trunk length < 20 mm.
- secondary hypertension with known causes and pseudo-hypertension.
- has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular accident within 6 months.
- has an implantable cardioverter defibrillator (ICD) or pacemaker.
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- requires respiratory support.
- is pregnant or planning to be pregnant.
- cardiovascular diseases with sever hemodynamic disorder.
- type 1 diabetes mellitus.
- currently enrolled in another investigational drug or device trial.
- civil disability or limited capacity for civil conduct.
- other conditions researchers considered unsuitable for enrolled in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Jing Huang, MD, 0086-13508312022, huangjing@cqmu.edu.cn
Jing Huang, MD
About this study
Official title: Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases
Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an important part in the autonomic nervous system regulation, especially in cardiovascular system, the modulation of the renal nerves used as a therapeutic strategy has been researched across the world. The purpose of this study is to evaluate and quantify the morphology changes in different diseases, make the modulation therapy more selective and effective.
Read the detailed description
People eligible for this study will be divided into 4 groups according to the eligibility criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure Group and Control Group), about 15 objects for each, totally 60 objects are going to be recruited.
Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An intravascular ultrasound examination will be taken after all of these have been done.
- Conditions
- Hypertension, Heart Failure
- Keywords
- Hypertension, Heart failure, Sympathetic hyperactivity, Renal nerve, Remodeling, Nerve remodeling
- Medical subject headings
- Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resistant hypertension | Not described | |
| Essential hypertension | Not described | |
| Chronic heart failure | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number increase of Renal nerves in patients with sympathetic over-activity diseases
Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;
Measured: A duration of the whole research stage, an expected average of 1/2 year
Area increase of Renal nerves in patients with sympathetic over-activity diseases
Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);
Measured: A duration of the whole research stage, an expected average of 1/2 year
The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
- Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²);
- Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²);
- Total area of the renal nerve/Total renal artery area: percentage (%);
- Total area of the renal nerve/Total renal arterial wall area: percentage (%);
Measured: A duration of the whole research stage, an expected average of 1/2 year
Secondary outcomes (1)
Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including:
- Emerging renal artery dissection;
- Emerging renal artery stenosis, which will not improve by the intravascular injection of nitroglycerin;
- Emerging renal artery rupture or perforate;
- Contrast-induced nephropathy
- Any other complications related to this intervention procedure, such as catheter breakage, infection, hematoma ect.
Measured: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Jing Huang, MD, Principal investigator, Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243514
- Sponsor's protocol ID
- US-RNRE
- Other IDs
- NSFC81370440
- Status last verified
- Oct 2014
- First submitted
- 16 Sep 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PubMed 24678939D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.
PubMed 24292688
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases
- ClinicalTrials.gov ID
- NCT02243514
- Acronym / sponsor ID
- US-RNRE
- Conditions
- Hypertension, Heart Failure
- Keywords
- Hypertension, Heart failure, Sympathetic hyperactivity, Renal nerve, Remodeling, Nerve remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 18 Sep 2014 (estimated)
- 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.
Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an important part in the autonomic nervous system regulation, especially in cardiovascular system, the modulation of the renal nerves used as a therapeutic strategy has been researched across the world. The purpose of this study is to evaluate and quantify the morphology changes in different diseases, make the modulation therapy more selective and effective.
Detailed description
People eligible for this study will be divided into 4 groups according to the eligibility criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure Group and Control Group), about 15 objects for each, totally 60 objects are going to be recruited.
Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An intravascular ultrasound examination will be taken after all of these have been done.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resistant hypertension | – | – |
| Essential hypertension | – | – |
| Chronic heart failure | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients who are going to take a vascular interventional examination.
Key inclusion criteria (17 listed)
- Resistant hypertension group
- Essential hypertension group
- Chronic heart failure group
- Control group
- All patients have full capacity for civil conduct and agree to sign the Medical Informed Consent.
Key exclusion criteria (13 listed)
- hemodynamically or anatomically significant renal artery stenosis.
- renal artery variation.
- renal artery diameter < 4 mm, trunk length < 20 mm.
- secondary hypertension with known causes and pseudo-hypertension.
- has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular accident within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number increase of Renal nerves in patients with sympathetic over-activity diseases
Time frame: A duration of the whole research stage, an expected average of 1/2 year
Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;
Area increase of Renal nerves in patients with sympathetic over-activity diseases
Time frame: A duration of the whole research stage, an expected average of 1/2 year
Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);
The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
Time frame: A duration of the whole research stage, an expected average of 1/2 year
1. Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²); 2. Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²); 3. Total area of the renal nerve/Total renal artery area: percentage (%); 4. Total area of the renal nerve/Total renal arterial wall area: percentage (%);
1 secondary outcome
Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
Time frame: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Background: PubMed 24678939Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
- Background: PubMed 24292688D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.
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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.
Jing Huang, MD principal investigator
Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Heart Failure, run by The Second Affiliated Hospital of Chongqing 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 17 inclusion and 13 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 23 Oct 2014. 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. 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 Jing Huang, MD (0086-13508312022, huangjing@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number increase of Renal nerves in patients with sympathetic over-activity diseases (time frame: A duration of the whole research stage, an expected average of 1/2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02243514, which also lists 2 linked publications.
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 23 Oct 2014.