Status:
ACTIVE_NOT_RECRUITING
Circulating RNAs in Acute Congestive Heart Failure
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Acute Congestive Heart Failure
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
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 vit...
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 b...
Eligibility Criteria
Inclusion
- Age \>/= 18 years of age
- Assessment of LV function within the last year or planned during hospital admission
- Acute CHF diagnosis, requiring clinical signs and/or symptoms (including exertional or rest dyspnea, orthopnea or PND) AND
- N-terminal pro-BNP level \> 1000 pg/ml or BNP \> 400 pg/ml, OR
- 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)
- Clinical response to IV diuretic therapy (as judged by a physician)
Exclusion
- Hematocrit at time of consent \< 30%
- End-stage non-cardiovascular diseases
- Known HIV/AIDS
- Cirrhosis
- Hemodialysis-dependent renal failure
- Pregnancy (as adjudicated by patient history)
- Ventricular assist device support
- Acute mechanical support on admission
- Post-heart transplant
- Malignancy within the last 1 year or clinically active rheumatologic or autoimmune illnesses
Key Trial Info
Start Date :
August 17 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03345446
Start Date
August 17 2016
End Date
December 31 2026
Last Update
October 23 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215