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Lower-body Negative Pressure Exercise for Heart Failure
N/A
Recruiting
Led By Neil D Eves, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes of exercise onset
Awards & highlights
Study Summary
This trial aims to find ways to help people living with heart failure exercise more and improve their health, which has a high risk of hospitalization and death.
Who is the study for?
This trial is for adults with a specific type of heart failure where the heart stiffens and has trouble filling (HFpEF). They should have had symptoms needing treatment in the past year, be somewhat active but not heavily exercising, and their condition should be stable. People can't join if they've had severe heart issues like low ejection fraction or certain diseases, are very overweight, smoke recently, or exercise a lot.Check my eligibility
What is being tested?
The study tests whether using a special cycling machine that applies suction to the lower body helps people with HFpEF exercise more by preventing blood from pooling in their lungs. Participants will cycle under different pressure conditions to see how it affects breathlessness and exercise duration.See study design
What are the potential side effects?
Potential side effects may include discomfort due to the suction applied during cycling exercises. There might also be risks associated with physical exertion for those with heart conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated for heart failure symptoms within the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 minutes of exercise onset
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes of exercise onset
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to exercise limitation (Tlim)
Secondary outcome measures
Dyspnea
Other outcome measures
Lung
Left ventricular filling pressure
Cerebrovascular accident
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Heart Failure with Preserved Ejection Fraction (40 Participants)Experimental Treatment3 Interventions
Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg)
Group II: Healthy Controls (20 Participants)Active Control3 Interventions
Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg)
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,956 Total Patients Enrolled
8 Trials studying Heart Failure
5,706 Patients Enrolled for Heart Failure
Neil D Eves, PhDPrincipal InvestigatorThe University of British Columbia
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for heart failure symptoms within the last year.The pressure in the vein in your neck is too high.I use supplemental oxygen when I move around.I have a significant heart condition.You are not able to exercise or use a stationary bike.My heart's right ventricle is not functioning well, or I have a large inferior vena cava without collapse when I breathe in.You have a body mass index higher than 35, which means you are very overweight.You have smoked within the last 6 months.Your heart cannot be seen clearly on an echocardiogram.I need treatment for my heart valve or artery problem.You have been doing more than 150 minutes of moderate exercise each week recently.I haven't had heart inflammation, fluid around the heart, a recent heart attack, or heart surgery in the last 3 months.Your heart shows signs of being enlarged or not functioning properly based on specific measurements.I have heart failure with preserved ejection fraction, mild to moderate symptoms, and have been stable on my current heart medication for at least 2 months.Your resting blood pressure is very high (above 160) or very low (below 100).Your heart has specific issues based on an echocardiogram, such as an enlarged left atrium or certain abnormal measurements of heart function.Your NT-proBNP level is higher than 50 pmol/L if you have a regular heart rhythm, or higher than 150 pmol/L if you have atrial fibrillation in the past year.I am a healthy adult who is not very active or only exercises occasionally.I have a primary disease affecting my lungs, metabolism, kidneys, liver, muscles, or it is cancerous.Your heart's pumping ability (ejection fraction) has been measured and is less than or equal to 40%.I have been diagnosed with heart muscle disease.
Research Study Groups:
This trial has the following groups:- Group 1: Heart Failure with Preserved Ejection Fraction (40 Participants)
- Group 2: Healthy Controls (20 Participants)
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.
Are there vacancies available in this clinical research program?
"Affirmative, the clinicaltrials.gov website declares that this medical trial is presently recruiting participants. The study was initially published on October 24th 2022 and has been subsequently updated as of the same date. 60 patients are needed to be enrolled from 1 centre."
Answered by AI
How many participants has this research enrolled thus far?
"Affirmative. Clinicaltrials.gov data confirms that this research study, which was initially announced on October 24th 2022 is actively recruiting participants. The trial needs around 60 individuals from one medical centre to participate."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
University of British Columbia
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Recent research and studies
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