RECRUITING

Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort

Conditions

Long Haul COVID Postural Orthostatic Tachycardia Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms. The study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected.

Official Title

Comparative Cohort Study of Post-acute COVID-19 Infection With a Nested, Randomized Controlled Trial of Ivabradine for Those With Postural Orthostatic Tachycardia Syndrome.

Quick Facts

Study Start:2023-06-14

Study Completion:2024-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05481177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-80 2. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test 3. Meets criteria for 'long-haul' COVID-19 with symptoms \>12 weeks following acute illness 4. Able and willing to provide informed consent and participate for study duration 5. Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met 6. Access to a primary healthcare provider and proof of health insurance 1. Age 18-80 2. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test 3. Does not meet criteria for 'long-haul' COVID-19 4. Able and willing to provide informed consent and participate for study duration 5. Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met 6. Access to a primary healthcare provider and proof of health insurance 1. Age 18-80; Meets criteria for 'long-haul' COVID-19 1. Documented history of COVID-19 infection made available to study team 1914 2. Lack of documented history, but evidence of infection from sensitive antibody tests 2. Able and willing to provide informed consent and participate for study duration 3. Volunteers with or without LHC combined with POTS based on an increase in comparing the supine heart rate to standing heart rate \>20 beats per minute with a drop in systolic blood pressure less than 20 mm Hg or a drop in diastolic blood pressure less than 10 mm Hg will be included, OR additionally, volunteers with or without LHC and a 24-hour mean heart rate of 90 beats per minute or more (in sinus rhythm) will be diagnosed with IST and be included. 4. For females of childbearing age - willing to use a highly effective form of contraceptive with \<1% failure rate or practice abstinence for the duration of the study	1. Resting heart rate \<60 bpm 2. Atrial fibrillation 3. Supraventricular tachycardia 4. Allergic reaction or known contraindications to study drug 1. Acute decompensated heart failure 2. Clinically significant hypotension, defined as a drop in systolic BP \>20 mmHg or drop in diastolic \>10 mmHg during orthostatic vital signs testing. 3. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present 4. Clinically significant bradycardia 5. Severe hepatic impairment 6. Pacemaker dependence (heart rate maintained exclusively by the pacemaker) 7. Concomitant use of cytochrome P450 3A4 (CYP3A4) inhibitors or inducers 5. Pregnant/lactating females 6. Impaired gastrointestinal absorption that would preclude oral drug administration 7. Taking any of the following without discontinuation in consultation with the volunteer's healthcare provider and a one-week washout period: 1. ivabradine 2. beta-blockers 3. calcium- channel blockers 4. cholinesterase inhibitors (pyridostigmine), 5. vasoconstrictors (midodrine, octreotide, droxidopa, stimulants) 6. sympatholytics (clonidine, methyldopa) 7. blood volume enhancers (fludrocortisone, desmopressin, salt supplementation) 8. oral ketoconazole (contraindicated) 8. Acute suicidality identified at screening

Inclusion Criteria

Exclusion Criteria

1. Age 18-80
2. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
3. Meets criteria for 'long-haul' COVID-19 with symptoms \>12 weeks following acute illness
4. Able and willing to provide informed consent and participate for study duration
5. Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met
6. Access to a primary healthcare provider and proof of health insurance
1. Age 18-80
2. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
3. Does not meet criteria for 'long-haul' COVID-19
4. Able and willing to provide informed consent and participate for study duration
5. Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met
6. Access to a primary healthcare provider and proof of health insurance
1. Age 18-80; Meets criteria for 'long-haul' COVID-19
1. Documented history of COVID-19 infection made available to study team 1914
2. Lack of documented history, but evidence of infection from sensitive antibody tests
2. Able and willing to provide informed consent and participate for study duration
3. Volunteers with or without LHC combined with POTS based on an increase in comparing the supine heart rate to standing heart rate \>20 beats per minute with a drop in systolic blood pressure less than 20 mm Hg or a drop in diastolic blood pressure less than 10 mm Hg will be included, OR additionally, volunteers with or without LHC and a 24-hour mean heart rate of 90 beats per minute or more (in sinus rhythm) will be diagnosed with IST and be included.
4. For females of childbearing age - willing to use a highly effective form of contraceptive with \<1% failure rate or practice abstinence for the duration of the study

1. Resting heart rate \<60 bpm
2. Atrial fibrillation
3. Supraventricular tachycardia
4. Allergic reaction or known contraindications to study drug
1. Acute decompensated heart failure
2. Clinically significant hypotension, defined as a drop in systolic BP \>20 mmHg or drop in diastolic \>10 mmHg during orthostatic vital signs testing.
3. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present
4. Clinically significant bradycardia
5. Severe hepatic impairment
6. Pacemaker dependence (heart rate maintained exclusively by the pacemaker)
7. Concomitant use of cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
5. Pregnant/lactating females
6. Impaired gastrointestinal absorption that would preclude oral drug administration
7. Taking any of the following without discontinuation in consultation with the volunteer's healthcare provider and a one-week washout period:
1. ivabradine
2. beta-blockers
3. calcium- channel blockers
4. cholinesterase inhibitors (pyridostigmine),
5. vasoconstrictors (midodrine, octreotide, droxidopa, stimulants)
6. sympatholytics (clonidine, methyldopa)
7. blood volume enhancers (fludrocortisone, desmopressin, salt supplementation)
8. oral ketoconazole (contraindicated)
8. Acute suicidality identified at screening

Contacts and Locations

Study Contact

Roshila Mohammed, MBBS

CONTACT

(301) 318-6024

clinical.research.unit.53-ggg@usuhs.edu

Principal Investigator

David L Saunders, MD, MPH

PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Mark C Haigney, MD, FAHA

STUDY_CHAIR

Uniformed Services University of the Health Sciences

Study Locations (Sites)

Uniformed Services University

Bethesda, Maryland, 20814

United States

Collaborators and Investigators

Sponsor: Uniformed Services University of the Health Sciences

David L Saunders, MD, MPH, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences
Mark C Haigney, MD, FAHA, STUDY_CHAIR, Uniformed Services University of the Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14

Study Completion Date2024-09-01

Study Record Updates

Study Start Date2023-06-14

Study Completion Date2024-09-01

Terms related to this study

Additional Relevant MeSH Terms

Long Haul COVID
Postural Orthostatic Tachycardia Syndrome