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Tests treatment safety and results for Heart Failure with Preserved Ejection Fraction (HFPEF)
Official title Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study
ClinicalTrials.gov ID: NCT06826963
What this study is testing
- What it's testing
- This study is designed to evaluate the safety, feasibility, and effectiveness of a 12-week eccentric exercise program for older adults with sarcopenia (muscle loss) or sarcopenic obesity and chronic heart failure (HF). The program aims to improve physical performance, muscle strength, and overall health without causing excessive strain on participants.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85
You may be able to join if
- Participants must meet all of the following criteria:
- Age 65 to 85 years
- Diagnosed with stable heart failure (HF), defined as:
- Preserved left ventricular ejection fraction (≥50%) or
- Reduced ejection fraction (≤40%)
You likely can't join if
- Participants will be excluded if they meet any of the following conditions:
- Severe obstructive heart disease
- Aortic valve stenosis
- Severe arrhythmias identified during initial stress testing
- Intracavitary thrombosis
- Severe pulmonary hypertension (\>70 mmHg)
See the full eligibility criteria
- Participants must meet all of the following criteria:
- Age 65 to 85 years
- Diagnosed with stable heart failure (HF), defined as:
- Preserved left ventricular ejection fraction (≥50%) or
- Reduced ejection fraction (≤40%)
- Classified as New York Heart Association (NYHA) class 1, 2, or 3
- Meet the diagnostic criteria for sarcopenia or sarcopenic obesity:
- Sarcopenia: Impaired muscle strength with the Five-repetition chair stand test time \>15 seconds (normal weight) or \>17 seconds (patients with obesity)
- Reduced muscle mass according to the European Working Group on Sarcopenia (EWGSOP) or Sarcopenic Obesity: Based on the European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the...
- For EWGSOP: Sarcopenia as Class I: Skeletal muscle mass index (kg/m²)
- Males: ≤10.75 kg/m²
- Females: ≤6.75 kg/m²
- For EWGSOP: Sarcopenia as Class II: Skeletal muscle mass index (kg/m²)
- Males: ≤8.50 kg/m²
- Females: ≤5.75 kg/m²
- For ESPEN-EASO: Obesity: waist circumference calculated in centimeters (cm)
- Males: ≥102 cm
- Females: ≥ 88 cm Sarcopenia as Class I: Skeletal muscle index as a percentage of body weight (%)
- Males: 31.3-37%
- Females: 22.1-27.6% Sarcopenia as Class II:
- Males: \<31.5%
- Females: \<22.1%
- Participants will be excluded if they meet any of the following conditions:
- Severe obstructive heart disease
- Aortic valve stenosis
- Severe arrhythmias identified during initial stress testing
- Intracavitary thrombosis
- Severe pulmonary hypertension (\>70 mmHg)
- History of venous thromboembolism within the previous three months
- History of heart transplantation
- Medical conditions that significantly limit functional capacity beyond the impact of HF
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Verona, Verona, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.