An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism

Adrenal Artery Ablation Treats Primary Aldosteronism



Sponsors


Source

Third Military Medical University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant
hypertension. Current studies have shown that the activation of the
renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in
the central or local tissue are the key mechanisms of high blood pressure and its organ
damages.

The classical method for diagnosis of primary aldosteronism depends on the detection of
peripheral venous blood aldosterone level, which is incapable of accurate positioning
diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone
receptor inhibitors were the only treatment for primary aldosteronism. However, only about
35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated
by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need
long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause
hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.

Therefore, the investigators proposed that endovascular chemical partial ablation of the
adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the
potassium metabolism balance. In order to confirm the above effects, the investigators
conduct an open, prospective, positive controlled study in patients with primary
aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal
hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic
indexes, target organ damages were observed to explore the efficacy and safety of the
endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

Overall Status

Recruiting

Start Date

2017-10-01

Completion Date

2019-04-30

Primary Completion Date

2018-10-31

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change of 24-h average systolic blood pressure compared with the baseline
24 weeks

Secondary Outcome

Measure

Time Frame

Change of 24-h average systolic blood pressure between two groups
24 weeks
Change of anti-hypertensive regimen between two groups
24 weeks
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between two groups
24 weeks
Change of office systolic and diastolic pressure between two groups
24 weeks
Change of blood electrolytes(serum potassium and natrium in mmol/L)
24 weeks
Change of plasma aldosterone and 24-h urine aldosterone
24 weeks
Change of plasma renin
24 weeks
Change of plasma cortisol and 24-h urine cortisol
24 weeks
Change of liver enzymes (ALT, AST)
24 weeks
Change of serum creatinine
24 weeks
Change of fasting blood glucose
24 weeks
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
24 weeks

Enrollment

60

Conditions


Intervention

Intervention Type

Procedure

Intervention Name


Description

Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.

Arm Group Label

Intevention


Eligibility

Criteria

Inclusion Criteria:

- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone
levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition
test.

- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal
hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous
blood (AVS).

- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but
refused to surgical excision.

- Signed informed consent and agreed to participate in this study.

Exclusion Criteria:

- Aldosterone cancer.

- Hyperkalemia.

- Renal failure or the following history of nephropathy: serum creatinine 1.5 times
higher than the upper limit; dialysis history; or nephrotic syndrome.

- Secondary hypertension except the primary aldosteronism.

- Adrenergic insufficiency.

- Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and
cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and
other acute cardiovascular events.

- Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or
alcohol addicts.

- Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher
than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal
variceal history or portal shunt history.

- Coagulation dysfunction.

- Pregnant women or lactating women.

- Participated in other clinical trials or admitted with other research drugs within 3
months prior to the trial.

- Any surgical or medical condition which can significantly alter the absorption,
distribution, metabolism, or excretion of any study drug.

- Allergy or any contraindications for the study drugs, contrast agents and alcohol.

- Refused to sign informed consent

Gender

All

Minimum Age

30 Years

Maximum Age

60 Years

Healthy Volunteers

No


Location

Facility

Status

Contact

Investigator

The third hospital affiliated to the Third Military Medical University
Chongqing Chongqing 400042 China
Recruiting
Last Name: Hongbo He, MD.
Phone: 86-23-68757880
Email: [email protected]
Last Name: Zhiming Zhu, MD.
Role: Principal Investigator

Location Countries

Country

China


Verification Date

2018-06-01

Lastchanged Date

2018-01-06

Firstreceived Date

2017-12-24

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Third Military Medical University

Investigator Full Name

Zhiming Zhu

Investigator Title

Director of the department of Hypertension & Endocrinology, Daping Hospital


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Epinephrine

Racepinephrine

Epinephryl borate



Arm Group

Arm Group Label

Intevention

Arm Group Type

Experimental

Description

Adrenal Artery Ablation


Arm Group Label

Control

Arm Group Type

No Intervention

Description

No intervention, but treated with standard anti-hypertensive drigs



Firstreceived Results Date

N/A

Other Outcome

Measure

Change of testosterone and estrogen levels

Time Frame

24 weeks

Description

Change of testosterone and estrogen levels compared with baseline, and between the intervention and control group at the end of the study (24 weeks)


Measure

Change of 24-h urine microalbumin, microalbumin/creatinine ratio

Time Frame

24 weeks

Description

Change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with baseline, and between the intervention and control group at the end of the study (24 weeks)


Measure

Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM)

Time Frame

24 weeks

Description

Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)


Measure

Change of carotid intima-media thickness assessed by carotid ultrasound

Time Frame

24 weeks

Description

Change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound compared with baseline, and between the intervention and control group at the end of the study (24 weeks)


Measure

Change of electrocardiogram manifestations

Time Frame

24 weeks

Description

Change of electrocardiogram manifestations(heart rhythms, heart rates and arrhythmia ) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

December 24, 2017

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

June 26, 2018

Last Update Submitted Qc

June 26, 2018

Last Update Posted

June 27, 2018


ClinicalTrials.gov processed this data on June 27, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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