Exercise and Low-Dose Rapamycin in Older Adults With CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial

Completed · Phase 1

Conditions studied: Aging, CAD

In brief

The investigators will do the study in two phases. The first phase will be a pilot study on up to 18 participants \[patients 60 years or older with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)\]; up to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the duration of CR. Baseline and follow-up data will be collected for age-associated impairment (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory phenotype (SASP)and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes. Safety of rapamycin will be assessed by periodic clinical follow-up, blood draws, and serum rapamycin levels. Following completion of the pilot phase, the data will be analyzed. If favorable changes are noted in the SASP or AAI, the investigators will start a phase 2 randomized trial. Second phase: In a prospective, randomized, clinical trial design, patients 60 years or older will be randomized at the time of CR to a standardized exercise protocol, or exercise protocol with the addition of low-dose rapamycin to test the hypothesis whether low-dose rapamycin (demonstrated in the pilot trial to improve SASP/AAI) will improve measures of AAI, SASP, or findings on the fat biopsy as compared to exercise alone. The null hypotheses are that there is no improvement with rapamycin in measures of AAI or SASP.

Key facts

Study ID

NCT01649960

Run by

Mayo Clinic

People needed

13

Starts

2012-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-12-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 60 years or older
• Patients eligible to undergo cardiac rehabilitation.
• Informed written consent.

You may not qualify if…

• Class III or IV CHF.
• Creatinine > 2.0 mg/dl.
• HbA1c > 13%.
• Any malignancy
• Hematological disorder, including thrombocytopenia, leucopenia.
• Noncardiac illness expected to limit survival.
• Chronic liver disease.
• Suspected or known pregnancy.
• Geographically inaccessible or unable to return for follow-up.
• Unable to understand or cooperate with protocol requirements.
• Post organ transplant or with immune-compromised status
• Prior stroke with disability, severe Parkinson disease
• Dementia
• Post-CABG <3 months or any evidence of active wounds or ulcers.
• Anticipating elective surgery in the 3 months following enrollment.

Where it is running

• Mayo Clinic in Rochester and Mayo Health System sites in Austin and Albert Lea, Minnesota — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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