Heart Failure Clinical Trial
— CROMeOfficial title:
Cardiac Rehabilitation Outcomes and Metabolomic Profiles Among Patients With Heart Failure in Western Kenya
Verified date | November 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled trial of participants with heart failure randomized into
usual care plus integrated cardiac rehabilitation or usual care only. The rehabilitation
protocol will comprise one month of thrice weekly sessions including supervised aerobic
exercises and counseling, followed by two months of monitored home based exercises prescribed
weekly.
Cardiopulmonary performance status, depression and quality of life will be assessed at
enrollment and upon completion of the protocol using the 6-minute walk time distance test.
Plasma samples will be collected and bio-banked for metabolomic profiling and comparative
outcome analysis.
Status | Completed |
Enrollment | 91 |
Est. completion date | October 31, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. NYHA Class II or III heart failure 2. Owns a mobile telephone 3. Can participate in supervised exercise three times a week 4. Can read/ primary care giver can read in English or Kiswahili Exclusion Criteria: 1. Recent acute illness requiring hospitalization in the preceding 4 weeks. 2. Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced co morbidities. 3. Known uncontrolled arrhythmia. 4. Heart failure due to congenital heart disease. 5. Pregnant patients as may be confirmed by patient report or urine pregnancy tests 6. Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis. 7. Use of pacemakers. |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi teaching and Referral Hospital | Eldoret | Uasin Gishu |
Lead Sponsor | Collaborator |
---|---|
Duke University | Moi Teaching and Referral Hospital |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Metabolomic Profile | This study will secondarily describe pre - post intervention changes in metabolomic profiles in participants with heart failure as measured using mass spectroscopy | 3 months | |
Other | Inflammatory Profile | This study will secondarily describe pre - post intervention changes in markers of inflammation such as hsCRP, interleukin-6, TNF-a, and ICAM-1 in participants with heart failure. | 3 months | |
Primary | 6 minute walk time distance | This study seeks to find out whether 6 minute walk time distance among patients undergoing integrated cardiac rehabilitation is different when compared to usual care study participants. | 3 months | |
Secondary | Depression severity | Change in total depression screening scores using PHQ9 score | 3 months | |
Secondary | Quality of living | Change in quality of living total score as measured by the WHO quality of life scale. | 3 months |
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