NCT07059637 Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
| NCT ID | NCT07059637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-10 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sarcopenia, or skeletal muscle loss, impacts up to 40% of COPD patients and is a major cause for morbidity and mortality. Despite the high clinical significance of sarcopenia in COPD, the diagnosis remains elusive because accurate measures of skeletal muscle are not tested during routine clinical care. The goal is to use evidence-based strategies to diagnose and treat sarcopenia due to COPD. The multidisciplinary team includes a pulmonologist, pharmacist, COPD nurse, and COPD coordinator. The investigators anticipate that the approach will improve clinical outcomes for COPD patients with sarcopenia as compared to standard of care visits in ambulatory COPD clinics. The investigators will determine if the approach improves skeletal muscle mass and function, and also improves clinical outcomes related to frequency of hospitalization or ED (Emergency Department) visits, COPD exacerbations, and mortality.
Eligibility Criteria
Inclusion Criteria: 1. COPD exacerbation as the primary cause for inpatient hospitalization OR secondary diagnosis of COPD exacerbation with acute respiratory failure as the primary diagnosis. 2. Patients must have CT (Computed Tomography) imaging performed during their admission and evidence of low skeletal muscle mass determined by CT imaging of the pectoralis muscle 3. Age \> 40 years old. 4. Spirometry diagnosed COPD with FEV1/FVC ratio \<0.70 with at least moderate obstruction (FEV1; forced expiratory volume in 1 second \<80%). 5. Patients must have smoked at least 10 pack years and may be current or former smokers. Exclusion Criteria: 1. History of other comorbid lung disease (i.e. interstitial lung disease, asthma). 2. Currently being evaluated or already listed for lung transplant. 3. Active malignancy. 4. Significant comorbid end organ failure defined as congestive heart failure (ejection fraction\<40%), end stage renal disease requiring dialysis, or cirrhosis (based on radiologic imaging).
Contact & Investigator
Amy Attaway, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07059637 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059637 currently recruiting?
Yes, NCT07059637 is actively recruiting participants. Contact the research team at attawaa@ccf.org for enrollment information.
Where is the NCT07059637 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07059637 clinical trial?
NCT07059637 is sponsored by The Cleveland Clinic. The principal investigator is Amy Attaway, MD at The Cleveland Clinic. The trial plans to enroll 80 participants.
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