Heart Failure Clinical Trial
Official title:
A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome
Verified date | November 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the feasibility of administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC while also exploring its effects on age-related functional decline
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 80 Years |
Eligibility |
Inclusion Criteria: - English speaking elderly males and females, aged 65-80 years, referred by the Gerontology Department and the Cardiology Clinic of the Wake Forest Baptist Health Sticht Center for Aging. - a score of 3 or greater (at least frail status) as demonstrated by the Fried Frailty criteria. Exclusion Criteria: - Unable or unwilling to give informed consent in either study group - Current psychiatric disorder not currently under control or being adequately treated - Current consumption of more than 14 alcoholic drinks per week - Self-reported inability to walk across a small room - Residence in a nursing home - Previous MOCA score below 21 - Difficulty in communication with study personnel due to speech or hearing problems - Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol - Elective surgery, planned prior to signing consent - Severe osteoarthritis - Rheumatoid arthritis - Severe B/L hip, knee, or hand pain (>7/10 on pain scale) - Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) - Pulmonary disease including VQ mismatch/diffusion limitation, diminished inspired O2, hypoventilation, pulmonary fibrosis, or sarcoidosis - Current tobacco use (smoke/chew) - Currently prescribed corticosteroids - Patients taking nucleoside analogues (Zebularine, 5-azaC, Decitabine) - Patients on non-nucleoside analogues (Procaine, procainamide, hydralazine) - History of an inherited bleeding disorder or vitamin K deficiency - Cardiovascular disease (excluding HFpEF), clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator or uncontrolled angina. - Parkinson's disease or other serious neurological disorder - MMS score < 18 - Renal disease (any stage, inappropriate for age; Cr Cl < 60) - Hypoalbuminemia, with serum albumin level < 3.5 g/dL - History of IgA deficiency - History of hypersensitivity to frozen plasma (PF24) or to plasma-derived products including any plasma protein - Active hepatitis or history of liver transplant - Anemia or polycythemia: Male - Hgb level below 12 or above 17.5 g/dL and/or HCT of 41%-53%. Female: Hgb level below 10.0 or above 16.0 g/dL and/or HCT 36%-46% - Current use of anti-coagulants - History of DMI or DMII - Peripheral vascular disease - Brain aneurysm or intracranial hemorrhage within the past 6 months - History of Hepatitis B, Hepatitis C, or HIV infection - Other illness of such severity that life expectancy is considered to be less than 12 months - Patients with initial VO2max that falls below expected value or that does not meet a minimum VO2max of 20 mL * kg * min (in order to demonstrate a more clinically meaningful increase) - Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) - CVA, hip fracture, B/L hip or knee replacement, or spinal surgery in the past 6 months - Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG - Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolism in the past 6 months - Undergoing physical therapy or cardiopulmonary rehabilitation - Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions - Currently on an anaerobic/aerobic exercise plan - Inability or unwillingness to return for all transfusions/FU visits |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of adverse events | The primary outcomes of this phase 0 study are built upon evaluating the outcome of safety with administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC, as evidenced by lack of any grade 4-5 adverse events and >/=50% grade 3-4 adverse events, as defined by NCI CTCAE v5.0. Grade 1-2 events will be recorded for statistical purposes. | Post 5 weeks after the last infusion of plasma | |
Secondary | Study participant retention | Secondary outcomes include indicators of feasibility as assessed by measuring study participant retention >/= 80% | Post 5 weeks after the last infusion of plasma | |
Secondary | Study participants ability to complete the Fried Frailty Assessment | Measurement of the Fried Frailty Score - The stages of frailty based on the Fried Frailty assessment criteria: a score of 0 means that a person is robust or not frail. Persons with a score of 1 or 2 are at intermediate risk for adverse outcomes or are considered to be pre-frail. A score of 3-5 indicates that someone is frail | Study endpoint weeks 11 and 15 |
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