Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to see if the drug rapamycin will improve the heart's ability to pump by improving your oxygen consumption.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Age ≥60 years

• Diagnosis of HFpEF by either H2FEPF score of 6-9 or HFA-PEFF score of 5-6, or invasively confirmed diagnosis of HFpEF (resting pulmonary capillary wedge pressure ≥15mmHg or ≥25mmHg with exercise).

• Diagnosis of computable phenotype of frailty rests on screening questions about ability to climb two flights of stairs, activities of daily living, living environment, wearing of dentures/hearing aids, and whether the patient uses assistive devices.

Exclusion Criteria:

• Reduced ejection fraction (≤50%) with or without prior history of myocardial infarction

• Acute coronary syndrome <3 months

• Uncontrolled diabetes mellitus (HbA1C>8)

• Uncontrolled hypertension (>160/100mmHg, despite 3 antihypertensive medications)

• Nephrotic syndrome or eGFR <30mL/min/1.73m2

• Cirrhosis

• Hepatitis B/C positive

• Elevated lived enzymes (AST/ALT>3ULN

• Prior malignancy other than basal cell carcinoma

• History of ongoing, chronic or recurrent infectious disease

• Suspected/proven immunocompromised state

• Uncontrolled hyperlipidemia (fasting TG >400 mg/dL (>4.5 mmol/L) or total cholesterol >300 mg/dL (>7.8 mmol/L) despite maximum lipid lowering therapy

• Class IV HF symptoms