Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

Study acronym: UNLOAD-HF
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

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  1. Primary completion pushed from Sep 2026 to Sep 2027 Show 4 more changesShow less
    • Study completion pushed from Mar 2027 to Sep 2027
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 9 of 17 entries
    • Study description expanded, about 7 words
  2. Enrollment reduced: 210 → 156 participantsv12
  3. Eligibility criteria shortened, about 17 wordsv11
  4. Enrollment target: 402 to 210v10
  5. Primary endpoints: 3 to 1
    • Secondary endpoints: 15 to 17
    v9
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  1. Start date changed from estimate of Jul 2025 to Jun 20, 2025v8
  2. Start date: Jun 2025 to Jul 2025v7
  3. Start date: May 2025 to Jun 2025v6
  4. Primary completion date: Jan 30, 2026 to Sep 2026v5 Show 4 more changesShow less
    • Start date: Jul 16, 2024 to May 2025
    • Primary endpoints: 1 to 3
    • Study completion date: Jun 30, 2027 to Mar 2027
    • Eligibility criteria shortened, about 8 words
  5. Primary completion date: Sep 30, 2026 to Jan 30, 2026v4
  6. Start date changed from estimate of Jul 2024 to Jul 16, 2024v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2024 to Jul 2024
    • Study sites: 0 to 2
    • Secondary endpoints revised (15)
    v2
  1. Study First Submitted
  • 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.
Johns Hopkins University
509 trials monitored
See 41 trials at risk
Heart Disease
8,814 trials monitored
See 428 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
and 2 more diseases
This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.
Trial Details
NCT Number NCT06364644
Lead Sponsor Johns Hopkins University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)		 Type2diabetes, Heart Failure, Obesity
Related terms Diabetes Mellitus, Heart Failure, Motor Activity, Obesity
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov