Primary Aldosteronism Due to Aldosterone Producing AdenomaRSDAHNCT02642445

Renal Sympathetic Denervation From The Adventitia on Hypertension

A study testing Renal Sympathetic Denervation in people with Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Primary Aldosteronism Due to Aldosterone Producing Adenoma
What is being tested?: Renal Sympathetic Denervation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: Dec 2016to 31 Dec 2019
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

. Renal artery diameter ≥4 mm and Length ≥20 mm;
. 18 years old ≤ age ≤ 70 years old;
. Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study;
. Clinic systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥95 mmHg) .
. 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;
. Estimated GFR (eGFR)≥45 ml/min / 1.73 m2.

Who cannot join

. Renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); Underwent renal artery balloon angioplasty or inserting a stent; Renal artery anatomy apparently is unusual to insert catheter;
. Cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; Thrombus or unstable plaques in the arteries with extensive atherosclerosis; Hemodynamic apparently change in patients with heart valve disease;
. The patients with typeⅠdiabetes;
. Other serious organic disease;
. Participated in other clinical research.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhengzhou university People's Hospital
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism

Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. This study intends to conduct renal sympathetic denervation ablation from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Read the detailed description

This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Being tested: Renal Sympathetic Denervation
Keywords: Renal sympathetic denervation;hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renal Sympathetic DenervationDevice
We applied a ablation catheter for discrete radiofrequency ablations of 8 W or less and lasting up to 2 min each to obtain up to four-six ablations separated both longitudinally and rotationally from the adventitia

Study groups in NCT02642445
Study group	Role	What they receive
Renal Sympathetic Denervation	Experimental	Renal sympathetic Denervation are conducted from the adventitia of renal artery Receives: Device: Renal Sympathetic Denervation
Control Group	No intervention	Renal Sympathetic Denervation are not conducted in control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months
Measured: at 6 months,12 months,18 months

Secondary outcomes (2)

Change from Baseline Renin at 6 months,12 months, 18 months
The Change of Renin from Baseline to 6 months,12 months, 18 months
Measured: at 6 months,12 months,18 months
Change from Baseline aldosterone at 6 months,12 months, 18 months
The Change of aldosterone from Baseline to 6 months,12 months, 18 months
Measured: at 6 months,12 months,18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201631 Dec 2019

First posted30 Dec 2015 (estimated)
Study startDec 2016
Primary completion31 Mar 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Aldosteronism Due to Aldosterone Producing AdenomaStudies 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: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02642445
Sponsor's protocol ID: HenanICE201502
Acronym: RSDAH
Status last verified: Oct 2020
First submitted: 19 Dec 2015
Last updated: 3 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
Recruiting
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Primary Aldosteronism Due to Conn Adenoma, Radiofrequency Ablation Treatment

All Primary Aldosteronism Due to Aldosterone Producing Adenoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
ClinicalTrials.gov ID: NCT02642445
Acronym / sponsor ID: RSDAH / HenanICE201502
Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Keywords: Renal sympathetic denervation;hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
Study start: Dec 2016
Primary completion: 31 Mar 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 30 Dec 2015 (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.

Detailed description

This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Renal Sympathetic Denervation	Experimental	Device: Renal Sympathetic DenervationRenal sympathetic Denervation are conducted from the adventitia of renal artery
Control Group	No intervention	–Renal Sympathetic Denervation are not conducted in control group.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

. Renal artery diameter ≥4 mm and Length ≥20 mm;
. 18 years old ≤ age ≤ 70 years old;
. Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study;
. Clinic systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥95 mmHg) .
. 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;

Key exclusion criteria (5 listed)

. Renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); Underwent renal artery balloon angioplasty or inserting a stent; Renal artery anatomy apparently is unusual to insert catheter;
. Cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; Thrombus or unstable plaques in the arteries with extensive atherosclerosis; Hemodynamic apparently change in patients with heart valve disease;
. The patients with typeⅠdiabetes;
. Other serious organic disease;
. Participated in other clinical research.

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
Renal Sympathetic DenervationWe applied a ablation catheter for discrete radiofrequency ablations of 8 W or less and lasting up to 2 min each to obtain up to four-six ablations separated both longitudinally and rotationally from the adventitia	Device	Renal Sympathetic Denervation

Primary outcome

Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
Time frame: at 6 months,12 months,18 months
The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months

2 secondary outcomes

Change from Baseline Renin at 6 months,12 months, 18 months
Time frame: at 6 months,12 months,18 months
Change from Baseline aldosterone at 6 months,12 months, 18 months
Time frame: at 6 months,12 months,18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.

Related trials for Primary Aldosteronism Due to Aldosterone Producing Adenoma

Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
Recruiting
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Primary Aldosteronism Due to Conn Adenoma, Radiofrequency Ablation Treatment

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.

ChuanYu Gao, Dr. principal investigator

Henan Institute of Cardiovascular Epidemiology

Dayi Hu, Dr. principal investigator

Henan Institute of Cardiovascular Epidemiology

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 Sympathetic Denervation in people with Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Henan Institute of Cardiovascular Epidemiology 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Nov 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months (time frame: at 6 months,12 months,18 months). 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 NCT02642445.

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 3 Nov 2020.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (6 listed)

Key exclusion criteria (5 listed)

Interventions

Primary outcome

Results and safety

Research links

Related trials for Primary Aldosteronism Due to Aldosterone Producing Adenoma

Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)

Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension

Referral and contact

Questions about this trial