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NCT06409624

Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 9 months later, primary endpoint(s) modified.

See at-risk trials from University of Giessen

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Oct 2027v7 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reopened
    • Eligibility criteria expanded, about 14 words
    • Enrollment increased: 350 → 400 participants
    • Study completion pushed from Jul 2027 to Dec 2027
    • Study sites: 1 to 2
    • Secondary endpoints revised (3)
    • Collaborators: 2 to 4
  2. Enrollment target: 200 to 350v6 Show 5 more changesShow less
    • Primary completion date: May 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 34 words
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2026 to Jul 2027
    • Site details revised
  3. Eligibility criteria expanded, about 15 words
    • Primary endpoint revised
    • Secondary endpoints revised (3)
    v5
  4. Eligibility criteria expanded, about 2 wordsv4 Show 4 more changesShow less
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 8 words
    • Collaborators expanded, about 10 words
    • Study title expanded, about 1 word
  5. Start date changed from estimate of May 2024 to May 31, 2024v3
  6. Secondary endpoints expanded, about 5 wordsv2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Major adverse kidney events
Timeframe: Baseline to 12 months
Worsening PH or HF
Timeframe: Baseline to 12 months

Secondary (3)

All-cause mortality
Kidney function decline
Pulmonary hypertension-related death

Arms and interventions

Pulmonary hypertension

Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment

No pulmonary hypertension

Patients in whom PH was excluded by right heart catheterization

Other: No intervention is planned as part of the study

Sites

2 sites in 1 country