Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism
ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChongqing Medical University
About this trial
The goal of this clinical trial is to evaluate whether an intensive blood pressure control strategy (systolic blood pressure target \<120 mmHg) is more effective than a standard strategy (systolic blood pressure target \<140 mmHg) in reducing the risk of cardiovascular events in patients with primary aldosteronism.
The main question it aims to answer is: Does the intensive blood pressure control strategy reduce the risk of composite cardiovascular events more than the standard strategy in patients with primary aldosteronism? The study employs a randomized design, allocating participants in a 1:1 ratio to either the Intensive Treatment Group or the Standard Treatment Group. Researchers will compare the differences in cardiovascular outcomes and safety profiles between the two groups over a planned follow-up period of 6 to 10 years.
Participants will:
Undergo randomization and adhere to the assigned blood pressure management protocol.
Attend regular follow-up visits for blood pressure measurement, laboratory tests, questionnaires, etc.
Report any adverse events or changes in health status.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A diagnosis of PA meeting the following criteria: an upright plasma aldosterone-to-renin ratio (ARR) ≥20 (pg/mL)/(μIU/mL) or ≥300 (pg/mL)/(ng/mL/h); and at least one positive confirmatory test: plasma aldosterone ≥110 pg/mL after the captopril challenge test (CCT) or plasma aldosterone ≥80 pg/mL after the seated saline infusion test (SSIT).
Systolic blood pressure of 140-190 mmHg (or currently receiving antihypertensive treatment).
Previous history of clinical CVD (≥ 3 months)
Stroke
Disqualifiers
Patients with PA who are planned to undergo adrenal surgical treatment.
Other clearly diagnosed forms of secondary hypertension (excluding subclinical Cushing's syndrome and obstructive sleep apnea [OSA]).
Severe hypertension: systolic blood pressure (SBP) ≥190 mmHg or diastolic blood pressure (DBP) ≥110 mmHg.
Diastolic blood pressure <60 mmHg (without antihypertensive medication).
Trial design
Design model
Parallel
Treatments tested in this trial
Intensive BP control
DrugAdjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg.
Standard BP control
DrugAdjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg.
Treatment groups
3,830 Participants
are divided into 2 treatment groupsGroup A: Intensive treatment groupExperimental treatment 1 intervention
Group B: Standard treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome: The number of composite cardiovascular events that occurred
A composite of major cardiovascular events, including nonfatal myocardial infarction, unstable angina, nonfatal stroke, hospitalization or treatment for heart failure, atrial fibrillation, coronary or non-coronary revascularization, and cardiovascular death.
Time frame
Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years).Secondary outcomes
1
Expanded Outcome (Primary Outcome + All-Cause Death)
Time frame
Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years).2
Major Coronary Artery Disease (Non-fatal myocardial infarction, Unstable angina, Coronary revascularization, Death from coronary heart disease)
Time frame
Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years).3
Total Myocardial Infarction (Fatal and Non-fatal)
Time frame
Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631events are reached (anticipated follow-up: 6-10 years).4
Total Stroke (Fatal and Non-fatal)
Time frame
Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631events are reached (anticipated follow-up: 6-10 years).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chongqing Medical University
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Sponsor institution
First Affiliated Hospital of Chongqing Medical University
Collaborator
Source ClinicalTrials.gov