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Dietary Supplement
Calorie Protein Supplement for Advanced Heart Failure
N/A
Recruiting
Led By Mathew S. Maurer, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study Summary
This trial will test whether a high calorie, high protein diet can improve quality of life for people with advanced heart failure.
Who is the study for?
This trial is for adults over 18 with advanced heart failure, hospitalized at a specific center, with reduced heart function and mild malnutrition. It's not for those in nursing homes, with high potassium levels or severe kidney issues, cirrhosis, history of bariatric surgery or noncompliance to treatments, eating difficulties, allergies to the supplement, listed for heart transplant or poorly controlled diabetes.Check my eligibility
What is being tested?
The study tests if a high calorie and protein nutrition supplement can improve life quality in advanced heart failure patients compared to usual care. Participants will either receive this special diet strategy or continue with their regular dietary routine.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the change in diet and possible nutritional imbalances if the supplements don't align well with participants' health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Other outcome measures
Change in Short Physical Performance Battery (SPPB) Score
Change in handgrip strength
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Calorie and protein nutritional supplementationExperimental Treatment1 Intervention
Study participants randomized to the intervention will receive 30 days worth of the nutritional supplement (i.e. Ensure Original) to be consumed twice per day in between meals in addition to standard of care for heart failure.
Group II: ControlActive Control1 Intervention
The control group will receive standard of care for heart failure.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,437 Previous Clinical Trials
2,448,312 Total Patients Enrolled
20 Trials studying Heart Failure
6,201 Patients Enrolled for Heart Failure
Mathew S. Maurer, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
800 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had high levels of potassium in your blood multiple times while in the hospital, or have a history of very high potassium levels.Your kidneys are not working well, as measured by a test called estimated glomerular filtration rate.You have cirrhosis.You have had weight loss surgery in the past.You are 18 years old or older.You can't eat food by mouth.You are unable to eat by yourself.You are allergic to the nutritional supplement.You are on a waiting list for a heart transplant.Your heart's pumping ability is less than 40%.You are not malnourished according to the Subjective Global Assessment (SGA).You have diabetes that requires insulin, and your most recent A1c level is higher than 7%.You have a history of difficulty swallowing.You need extra heart support when leaving the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Calorie and protein nutritional supplementation
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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