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Clinical Trial NCT03345446 (CRUCiAL) for Acute Congestive Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Circulating RNAs in Acute Congestive Heart Failure (CRUCiAL) 200 Translation Available

Active, not recruiting
Clinical Trial NCT03345446 (CRUCiAL) is an observational study for Acute Congestive Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction that is active, not recruiting. It started on 17 August 2016 with plans to enroll 200 participants. Led by Massachusetts General Hospital, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 23 October 2025.
Brief Summary
The purpose of this American Heart Association-funded and NIH-funded study is to examine circulating RNAs in the acute CHF setting, how they change with decongestive therapy, and their function in vitro and in vivo.

The investigators are testing the hypothesis that ex-RNA levels change significantly during decongestion therapy and can be used as a marker of those individuals who respond to CHF therapy (in terms of c...

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Detailed Description
Nearly 5 million people in the United States have congestive heart failure (CHF). Although medical therapy such as beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains wo...Show More
Official Title

Circulating RNAs in Acute Heart Failure

Conditions
Acute Congestive Heart FailureHeart Failure With Reduced Ejection FractionHeart Failure With Normal Ejection Fraction
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT03345446
Start Date (Actual)
2016-08-17
Last Update Posted
2025-10-23
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
200
Study Type
Observational
Status
Active, not recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients with HF-rEF
These patients have Heart Failure with Reduced Ejection Fraction (EF \< 55% per the protocol).
Cardiac MRI
Cardiac MRI is a test that allows us to look at how the heart muscle works and the amount of scar tissue in your heart. Screening questions will be asked to make sure that patients are not pregnant, and that they have kidney function tests to confirm that IV contrast used (gadolinium) during the MRI is safe for them.
Patients with HF-pEF
These patients have Heart Failure with Preserved Ejection Fraction (EF \> 55% per the protocol).
Cardiac MRI
Cardiac MRI is a test that allows us to look at how the heart muscle works and the amount of scar tissue in your heart. Screening questions will be asked to make sure that patients are not pregnant, and that they have kidney function tests to confirm that IV contrast used (gadolinium) during the MRI is safe for them.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Plasma RNAs levels (rpm by RNAseq) in patients with acute CHF
Identification of plasma RNAs (absolute reads per million) by RNA sequencing in 1 ml of plasma that are greater than 2 fold increased with p value \< 0.05.
admission vs. decongestion (up to 2 weeks)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Correlation of plasma RNA levels (rpm by RNAseq) with CMR measurements of ventricular function and in vitro fibroblast proliferation assay.
Correlation (by PCA regression models) of candidate plasma RNAs (absolute reads per million) identified in the primary outcome with cardiac MRI phenotypes, including extracellular volume fraction or ECV (unit less), LV ejection fraction (percentage), LV systolic volume (ml) and in vitro fibroblast proliferation by MTT assay (absorbance at 490 nm).
6 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  1. Age >/= 18 years of age

  2. Assessment of LV function within the last year or planned during hospital admission

  3. Acute CHF diagnosis, requiring clinical signs and/or symptoms (including exertional or rest dyspnea, orthopnea or PND) AND

    1. N-terminal pro-BNP level > 1000 pg/ml or BNP > 400 pg/ml, OR

    2. Clinical evidence of congestion:

      • X-ray evidence of pulmonary edema or pleural effusions
      • Elevated JVP, lower extremity edema, or rales on pulmonary examination
      • Right heart catheterization evidence of elevated filling pressures (RA pressure > 10 mmHg; PCWP > 18 mmHg)

  4. Clinical response to IV diuretic therapy (as judged by a physician)

  1. Hematocrit at time of consent < 30%

  2. End-stage non-cardiovascular diseases

    1. Known HIV/AIDS
    2. Cirrhosis
    3. Hemodialysis-dependent renal failure

  3. Pregnancy (as adjudicated by patient history)

  4. Ventricular assist device support

  5. Acute mechanical support on admission

  6. Post-heart transplant

  7. Malignancy within the last 1 year or clinically active rheumatologic or autoimmune illnesses

Massachusetts General Hospital logoMassachusetts General Hospital
Study Responsible Party
Saumya Das, Principal Investigator, Co-Director of Resynchronization and Advanced Cardiac Therapeutics Program, Massachusetts General Hospital
No contact data.
3 Study Locations in 1 Countries

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States