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DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

Study acronym: DRAIN-IT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion moved earlier from Oct 2029 to Feb 2029
    • Study completion moved earlier from Mar 2030 to Jun 2029
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 6 entries
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to assess if removal of fluid around the lungs (pleural effusion) by a routine procedure called as thoracentesis is helpful to decrease shortness of breath in hospitalized patients with congestive heart failure and have pleural effusion. Researchers will compare thoracentesis with medical therapy to medical therapy alone to see if one treatment is superior to the other treatment in relieving shortness of breath. Participants will : 1. Receive medical therapy with or without thoracentesis 2. Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales. 3. Telephonic call for 15- 30 mins at day 14 and 30 after enrollment to assess shortness of breath and quality of life
Trial Details
NCT Number NCT07419360
Lead Sponsor Albany Medical College
Conditions
(from sponsor)		 Congestive Heart Failure(CHF), Pleural Effusion Due to Congestive Heart Failure
Related terms Dyspnea, Heart Failure, Pleural Effusion
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov