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Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04996719
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Mandeep Singh, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Rapamune Phase 1

Detailed Description:
This will be a pilot, proof-of-concept study. Patients 60 years or older with invasively proven HFpEF or have definite HFpEF as determined by the 2 established scores and frailty (positive screen for computable phenotype), will be approached for enrollment. Subjects meeting screening criteria following written informed consent will be randomized to receive rapamycin or matching placebo (study drug). Efficacy outcomes will be measured at baseline and at 6 months. Safety will be assessed by in person or remote video monitoring weekly for 1 month, then monthly for 5 months till the end of the study. We will also measure trough rapamycin levels (≤4ng/mL) twice-a-month for the first month and then monthly for 5 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults With Heart Failure With Preserved Ejection Fraction: A Randomized Pilot and Proof-of-Concept Study
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Rapamycin
find safe doses for patients who have heart failure with preserved ejection fraction
Drug: Rapamune
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).
Other Name: Rapamycin




Primary Outcome Measures :
  1. Change cardiopulmonary reserve capacity by improving peak VO2 with rapamycin [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04996719


Contacts
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Contact: Colleen M Irlbeck 507-266-6879 Irlbeck.Colleen@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Colleen M Irlbeck    507-266-6879    Irlbeck.Colleen@mayo.edu   
Principal Investigator: Mandeep Singh, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mandeep Singh, MD Mayo Clinic
Additional Information:
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Responsible Party: Mandeep Singh, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04996719    
Other Study ID Numbers: 21-003837
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs