NCT04345198

Brief Summary

Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized. With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

April 5, 2020

Last Update Submit

April 11, 2020

Conditions

Resistant Hypertension

Keywords

resistant hypertension; aldosteronism

Outcome Measures

Primary Outcomes (1)

  • Change of office systolic blood ptressure

    Change of office systolic blood pressure compared with baseline after 24 weeks.

    24 weeks

Secondary Outcomes (10)

  • Change of office dystolic blood pressure

    24 weeks

  • Change of home systolic blood pressure

    24 weeks

  • Change of home diastolic blood pressure

    24 weeks

  • Change of 24-h average systolic blood pressure

    24 weeks

  • Change of 24-h average diastolic blood pressure

    24 weeks

  • +5 more secondary outcomes

Study Arms (1)

Intervension

EXPERIMENTAL

Adrenal artery ablation is performed in PA patients with resistant hypertension.

Procedure: Adrenal Artery Ablation

Interventions

Adrenal Artery AblationPROCEDURE

Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.

Intervension

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age between 30-65 years old.
  • Primary aldosteronism with resistant hypertension.
  • Informed consent signed and agreed to participate in this trial.

You may not qualify if:

  • Secodary hyertension due to other causes.
  • History of depression,schizophrenia or vascular dementia .
  • History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
  • Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
  • Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  • Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  • Fertile woman without contraceptives.
  • Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
  • Allergic to or have contraindication to the contrast agents and alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 14, 2020

Study Start

October 1, 2017

Primary Completion

April 15, 2019

Study Completion

October 15, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)