Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults

NCT04996719 | Completed Phase 1 FDA Drug

• 1 other identifier: 21-003837
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change cardiopulmonary reserve capacity by improving peak VO2 with rapamycin

  In this pilot, proof-of-concept study, we hypothesize that in older adults (≥60 years) with HFpEF who are frail, chronic rapamycin administration will change their cardiopulmonary reserve capacity by improving peak VO2.Primary safety objective is the safety of rapamycin.

  6 months

Study Arms (1)

Rapamycin

EXPERIMENTAL

find safe doses for patients who have heart failure with preserved ejection fraction

Drug: Rapamune

Interventions

Rapamune DRUG

We will start the dose at 0.5mg capsule every other day for 2 weeks. If participants tolerate this dose and trough blood levels are (≤4ng/mL), the dose of rapamycin will be increased to 0.5mg daily for the duration of the study. If necessary, dose can remain at 0.5 mg every other day, depending on the trough level. To avoid immunosuppression, we will target lower dose of rapamycin, maintain lower trough serum levels (≤4ng/mL).

Also known as: Rapamycin

Rapamycin

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Mandeep Singh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 9, 2021
• Study Start: May 24, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)