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Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism

Study acronym: Intensia-Aldo
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Jun 2026 to Jul 7, 2026
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07673445
Lead Sponsor Chongqing Medical University
Collaborators: First Affiliated Hospital of Chongqing Medical University
Conditions
(from sponsor)
Primary Aldosteronism
Related terms Hyperaldosteronism
Enrollment 3,830 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov